FUMITOXIN - TABLETS

Main information

  • Trade name:
  • FUMITOXIN COATED INSECTICIDE TABLETS
  • Pharmaceutical form:
  • TABLET (INC. PELLET, BOLUS, SUPPOSITORY, CAPSULE)
  • Units in package:
  • 300g (100 Tabs), 1.5kg (500 Tabs)
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • NUFARM/PESTCON

Documents

Localization

  • Available in:
  • FUMITOXIN COATED INSECTICIDE TABLETS
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • FOOD PRODUCT/COMMODITY | GRAIN HANDLING MACHINERY | SHED,FACTORY,WAREHOUSE OR OTHER BUILDING | STORED BARLEY SEED | STORED BREAK
  • Therapeutic area:
  • Group 24A Insecticide
  • Therapeutic indications:
  • ANGOUMOIS GRAIN MOTH | BEAN WEEVIL | CADELLE | CIGARETTE BEETLE | COCKROACH | COFFEE BEAN WEEVIL | CONFUSED FLOUR BEETLE | DRIED FRUIT BEETLE | FLAT GRAIN BEETLE | GRANARY WEEVIL | HIDE OR SKIN BEETLE | INDIAN MEAL MOTH | LESSER GRAIN BORER | MAIZE WEEVIL | MEDITERRANEAN FLOUR MOTH | MERCHANT GRAIN BEETLE | MOTTLED GRAIN MOTH | MOUSE - MUS SPP. | PSOCIDS OR BOOKLOUSE | RAISIN MOTH | RAT | REDLEGGED HAM BEETLE | RICE WEEVIL | RUST-RED FLOUR BEETLE | SAWTOOTHED GRAIN BEETLE | SPIDER BEETLE | STORED PRODUCT MITE | TOBACCO MOTH | TROPICAL WAREHOUSE MOTH | WAREHOUSE BEETLE | DERMESTES ATER | DERMESTES MACULATUS | GRAIN BORER | LARGE COCKROACH | SMALL COCKROACH | TOBACCO BEETLE
  • Product summary:
  • For control of pests which infest stored commodities, specified processed foods and animal foods.See RESTRAINTS, etc. on label

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 32069/103019
  • Authorization date:
  • 16-11-2015
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

DANGEROUS POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Fumitoxin

®

Coated Insecticide Tablets

ACTIVE CONSTITUENT: 330g/kg PHOSPHINE

(PH

3

) present as ALUMINUM PHOSPHIDE

Each 3g Tablet liberates 1g PHOSPHINE (PH

3

)

GROUP

INSECTICIDE

For control of pests which infest stored commodities, specified processed

foods, and animal foods as per Directions for Use Table.

Net Contents: 100 Tablets (300g) 500 Tablets (1.5 kg)

4)

MINIMUM EXPOSURE PERIODS

are needed to allow products to react to completion and to expose insects for long

enough to kill all stages. A SHORTENED EXPOSURE PERIOD CANNOT BE COMPENSATED FOR BY INCREASED DOSAGE.

Insect death and reaction of the tablets are both slower at lower temperatures. Temperatures specified are those within

the commodity to be fumigated. The minimum exposure period should start from time of completion of application of

product.

5)

VENTILATION PERIOD – ON COMPLETION OF EXPOSURE PERIOD:

Ventilation of structures is complete only when phosphine concentrations measured at appropriate locations in the en-

closure and work area are below the Threshold Limit Value–Time Weighted Average (TLV-TWA) exposure standard of 0.3

ppm. The following are minimum ventilation periods required and may need to be increased to ensure the exposure stan-

dard is not exceeded.

Minimum Ventilation Periods:

Structures, including bunker storages, containing treated commodities:

Without throughflow (i.e. access only through the headspace): not less than 5 days

With throughflow and natural draught (wind): For structures of 300 tonnes or greater capacity: 2 to 5 days de-

pending on size. For structures of less than 300 tonnes capacity: 2 days

With throughflow and forced draught (flash-proof fan) operated 2 hours on and 2 hours off: not less than 1

day.

Tobacco:

In bales: not less than two days. In cases and hogsheads: not less than 3 days.

Empty Buildings and Enclosures:

Without throughflow: 5 days

With throughflow and natural draught (wind): For structures of 300 tonnes or greater capacity: not less than 2

days, depending on structure size, openings and prevailing wind speed. For structures of less than 300 tonnes

capacity: 2 days.

Distributed by: Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road Laverton

North Victoria 3026

Tel: (03) 9282 1000

For: Sunzon International

902/10 Martin Place

Sydney, NSW 2000

NOTES:

1)

FUMIGATION WILL CONTROL ALL STAGES OF INSECTS ONLY IN STRUCTURES/ENCLOSURES THAT ARE

WELL SEALED*

Well sealed structures/enclosures are fumigation chambers, well sealed silos, sheds and buildings, and other fumigation enclosures

made gas-tight with gas-proof sheeting. Well sealed means permanent sealing of porous surfaces, seams and cracks and tem-

porary sealing of intake and/or outlet valves, doors, fan housings, windows and hatches. For further information see appropriate

industry advisory documents such as Grains Research and Development Corporation ‘Advice’ sheet ‘$ealed $ilos $ave’, available

With throughflow and forced draught (flash-proof fan) operated 2 hours on and 2 hours off: 1 to 2 days de-

pending on size of structure

Beehives, supers and other beekeeping equipment:

not less than 2 days.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER

APPROPRIATE LEGISLATION

WITHHOLDING PERIOD:

DO NOT USE TREATED PRODUCE FOR HUMAN CONSUMPTION OR FOR STOCK FOOD FOR 2 DAYS AFTER COMPLETION

OF FUMIGATION (MINIMUM EXPOSURE PERIOD PLUS VENTILATION PERIOD).

TOBACCO:NOTREQUIREDWHENUSEDASDIRECTED.

TREATED COMMODITIES MAY BE SHIPPED AFTER COMPLETION OF THE MINIMUM EXPOSURE PERIOD PLUS VENTILATION

PERIOD.

GENERAL INSTRUCTIONS:

Fumitoxin releases phosphine gas when exposed to air. Phosphine penetrates throughout the commodity to kill eggs,

larvae, pupae and adult stages of storage pests in sealed enclosures, but some eggs, pupae and adults will survive in un-

sealed enclosures (See Note 1 above).

Protect by sealing or otherwise, sensitive electrical and electronic equipment (computers, meters, switches, fire alarm

systems, etc.) containing copper/copper alloy components, photographic film or copy paper. Phosphine corrodes copper

based materials.

WARNING:

Containers must be opened in the open air. Whilst opening containers take care and point containers away

from the face and body, as under certain conditions possible build-up of gas may result in flash flame

upon exposure to air.

Application rates higher than label directions and contrary to label instruction could cause the gas con-

centrations to reach the lower flammability level which is 1.79% by volume (17,900 parts per million).

When used according to the label directions, the amount of gas produced remains far below the

lower flammability level.

RE-ENTRY PERIOD:

After application, wait until the Exposure Period has passed, then thoroughly ventilate for the required Ven-

tilation Period and to the required Standard. Re-entry to fumigation areas is not recommended until meas-

uring device(s) indicate that they are free of phosphine. The use of gas detection tubes or other measuring

devices is recommended for monitoring gas levels in fumigation areas as phosphine gas may still be

present even after treated commodities have been removed and fumigation areas ventilated.

DO NOT re-enter a storage after application has commenced or once treated grain/commodity has

been emptied without wearing a full face respirator with particulate (P1) and phosphine gas filter

cartridge (can- ister) or self-contained breathing apparatus, until a measuring device indicates that it is

free of phosphine or the Total fumigation period (minimum exposure period plus ventilation period) has

elapsed.

PROTECTION OF LIVESTOCK:

Disturbance of unreacted phosphide powder residue results in release of more phosphine gas. Residues

of phosphine gas or unreacted phosphide powder in treated grain/commodity will be harmful if fed to an-

imals, including poultry. Ensure feed is well mixed and that such residues are not present before feeding.

DO NOT feed treated grain/commodity to animals, including poultry, until the Total Fumigation Period (Ex-

posure plus Ventilation) plus the Withholding Period has expired.

PROTECTION OF WILDLIFE, FISH, CRUSTACEA AND ENVIRONMENT: This product is highly toxic to

wildlife. Dangerous to fish. DO NOT contaminate streams, rivers or water- ways with the chemical or used

containers.

STORAGE AND DISPOSAL:

Store in the closed, original container in a cool, dry, well ventilated locked area, out of reach of children

and unauthorised persons and away from all dwellings, animals, food, feedstuffs, seed and fertilisers. DO

NOT store or carry container in vehicle cabins (this includes glove compartments, luggage compart-

ments or other common air-spaces). Keep away from water and liquids. Water and many liquids

cause immediate release of phosphine from the product. Uncontrolled release of phosphine may result

in fire or explosion and release of gas will pose a serious risk of injury to workers and bystanders.

After fumigation with the product on trays/sheets remove the spent tablets and ensure residual

phosphide is destroyed be- fore disposal, e.g. by swamping with dilute acid or soapy water in open air

until

bubbling

ceases.

Triple

preferably

pressure

rinse

containers

before

disposal.

rinsings

spray

tank.

dispose

undiluted

chemicals

site.

recycling,

replace

return

clean

containers

recycler

designated

collection

point.

recycling,

break,

crush

puncture

deliver

empty

packaging

approved

waste

management

facility.

approved

waste

management

facility

available,

bury

empty

packaging

below

surface

disposal

specifically

marked

and set up for this purpose, clear of waterways, desirable vegetation and tree roots, in compliance with

DIRECTIONS FOR USE:

BEFORE

you use this product you must consider the following:

Timing of treatment –

DO NOT fumigate if it will be necessary to move grain/commodity before the

Total Fumigation Period has expired. Movement of treated commodities or empty containers during

application, fumigation exposure or ventilation risks exposure of transport and handling workers and

the public to harmful levels of phosphine and is contrary to label instructions.

The Total Fumigation Period is the sum of the time required for

exposure

to phosphine and the time

needed to

ventilate

the grain. A shortened Exposure Period will not be effective for storage pest control

and a reduced Ventilation Period poses a serious risk of phosphine gas poisoning to workers and by-

standers. In addition a Withholding Period of two days is required after completion of ventilation before

the grain is allowed to be used for human consumption or for animal feed. See Notes 4 & 5 for a

detailed description of the Minimum Exposure Period and the Ventilation Period.

Safety and handling of the product –

Phosphine is a highly dangerous fumigant and fumigation must

only be undertaken in situations where the safety of workers and the public can be ensured. Observe

all RESTRAINTS, PRECAUTIONS and instructions on the label.

RESTRAINTS:

DO NOT fumigate inhabited buildings.

DO NOT fumigate work situations where there is a risk that phosphine gas could leak from fumigation

enclosures into working areas.

DO NOT use on commodities, or in empty containers, railcars or vessels that are in transit or likely to

be in transit during the Exposure and/or Ventilation Periods.

DO NOT use in road, transport vehicles (including a truck or road hauled container).

DO NOT heap tablets. Heaped tablets limit gas release.

DO NOT add water to the tablets.

DO NOT use when the commodity temperature is less than 15° C or the relative humidity within the

structure is less than25% or,with raw cereal grains, when the moisture content is less than 9%.

DONOTapplyin structuresthatarenotwell sealed*.

DO NOT apply as a surface-only treatment in a structure whose height exceeds twice its width, unless

the structure/enclosure has a gas recirculation device fitted.

from State Departments of Agriculture or Primary Industries. Increasing the application rate will not compensate for gas loss

from an unsealed enclosure.

NOTE: STRUCTURES MUST BE WELL SEALED. IF THEY ARE NOT, FUMIGATION WILL NOT GIVE ADEQUATE CONTROL, AND

WOULD BE CONTRARY TO LABEL DIRECTIONS.

2) STORAGE PESTS

include: lesser grain borer, cadelle, cigarette beetle, confused flour beetle, dried fruit beetle, flat grain beetle,

merchant grain beetle, red-legged ham beetle, rust-red flour beetle, sawtoothed grain beetle, skin and hide beetle, spider beetles,

warehouse beetle, Angoumois grain moth, Indian meal moth, Mediterranean flour moth, mottled grain moth, raisin moth, tobacco

moth, tropical warehouse moth, psocids, stored products mites, bean weevil, coffee bean weevil, granary weevil, maize weevil,

pea weevil and rice weevil.

For control of the larger wax moth and the lesser wax moth in stored beehives, supers and other beekeeping equipment.

Approved treatment dosages will also kill any cockroaches, rats and mice present.

3) PHOSPHINE APPLICATION RATES

are based on the internal volume of the structures to be fumigated; they apply equally to full

or partly filled or empty structures and they apply to all commodities. The commodity equivalent rates (g/tonne) should only be

used when the commodity stowage factor is known, they apply only when the storage structures are full or nearly full or when

part-filled structures are dosed on the tonnage equivalents of their internal volumes. The calculated commodity equivalent dosage

must be based on the rate per volume. The application rate of 1.5 g phosphine per 1 metre

is equivalent to:

Application

Fumigation of Commodities in Silos and Bulk Storages:

Place the tablets in a single layer and separated from the commodity e.g.:–on non-flammable trays/sheets which are

evenly spread on the commodity surface inside the storage.

Fumigation of Commodities under Gas Proof Sheeting:

Place tablets spaced from each other on non-flammable sheets/trays evenly distributed between and/or alongside stacked

commodities in a manner that allows free circulation of gas. Ensure that the sheeting is sealed in a gas-tight manner after

application.

Fumigation of empty storages/enclosures:

Place tablets spaced from each other on non-flammable sheets/trays evenly spread in the enclosure; with application starting

at the furthest point from the exit door. Ensure the enclosure is made gas-tight. Lock and seal exit door after application.

INSECTICIDE RESISTANCE WARNING

GROUP

INSECTICIDE

For insecticide resistance management Fumitoxin Coated Insecticide Tablets (“Fumitoxin”) is a group 24A insecticide.

Some naturally occurring insect biotypes resistant to Fumitoxin and other Group 24A insecticides may exist through

normal

genetic variability in any insect population. The resistant individuals can eventually dominate the insect

population if Fumitoxin or other Group 24A insecticides are used repeatedly. The effectiveness of Fumitoxin on resistant

individuals could

be significantly reduced. Since occurrence of resistant individuals is difficult to detect prior to use,

Nufarm Australia

Limited accepts no liability for any losses that may result from the failure of Fumitoxin to control

resistant insects.

Application of Fumitoxin in unsealed storages/enclosures and use of low dose rates and shortened

exposure periods is

contrary to label instruction and will contribute to development of resistance.

FLAMMABLE:

Keep away from naked flame.

PRECAUTIONS:

Show the following warning sign prominently at all approaches to every fumigation site.

“DANGER – POISON GAS – KEEP AWAY”

Keep animals, children and unauthorised persons away from the area under treatment until the area is shown to be free

from phosphine as indicated by a gas measuring device.

relevant local, state or territory government regulations. Empty containers

and product should not be burnt.

SAFETY DIRECTIONS:

Very dangerous. Product releases dangerous phosphine gas slowly in moist air and immediately if wet.

Can kill if inhaled or swallowed. DO NOT inhale dust or vapour. Avoid contact with eyes and skin. Open

container in the open air. Keep away from water and liquids. Keep away from naked flame – forms toxic

gas. Use the entire contents in one operation; if not possible, (tablets only) seal container thoroughly with

waterproof ad- hesive tape or air-tight closure. Wash hands after use. When opening the container or

using the produce wear elbow length PVC gloves and full face piece respirator with combined dust and

gas cartridge (canister) or supplied air respirator. After each days use wash gloves and respirator (if rubber

wash with detergent and warm water).

FIRST AID:

If poisoning occurs, contact a doctor or Poisons Information Centre on 131126. DO NOT give direct mouth-

to-mouth resuscitation if swallowed. To protect rescuer, use air-viva, oxy-viva or one-way mask.

Resus- citate in a well-ventilated area.

MSDS:

Additional information is listed in the material safety data sheet for Fumitoxin available at

www.nufarm.com.au or call 03 9282 1000. MSDS should be readily available in all workplaces storing or using the

product.

CONDITIONS OF SALE:

“Any provisions or rights under the Trade Practices Act 1974 or relevant state legislation which cannot be excluded by

those statutes or by law are not intended to be excluded by these conditions of sale. Subject to the foregoing, all

warranties, conditions, rights and remedies, expressed or implied under common law, statute or otherwise, in

relation to the sale, supply, use or application of this product, are excluded. Nufarm Australia Limited and/or

its affiliates (“Nufarm”) shall not accept any liability whatsoever (including consequential loss), or howsoever

arising (including negligence) for any damage, injury or death connected with the sale, supply, use or application

of this product except for liability which cannot be excluded by statute.”

APVMA Approval No.: 32069/103019

B/N:

DOM:

DANGEROUS

WHEN

WET

4

PESTS/

COMMODITY/SITUATION

See Note 1 for description

of well sealed* and Note 2

for storage pests controlled

APPLICATION

See note 3

FUMIGATION PERIOD #

#(TOTAL OF THE MINIMUM

EXPOSURE PERIOD

PLUS VENTILATION PERIOD)

WITH-HOLDING

PERIOD

TOTAL OF

(Exposure +

Ventilation+

Withholding

BASIC RATE

g.phosphine

per m

DOSAGE

number of

tablets

per m3

MINIMUM

EXPOSURE

PERIOD

See Note 4

VENTILATION

PERIOD

See Note 5

Storage pests in:

Well-sealed*structures such

as:–

fumigationenclosures, grain

storage sheds, silos, and structures

which are suitable for fumigation;

Raw cereal grains (such as barley,

maize, millets, oats, rice, rye,

sorghum, triticale, wheat);Other

foodcommodities(such as flour and

other milledcereal products, break-

fast cereals, dried fruits, dried

vegetables,driedpulses,other dried

foods, peanuts, oilseeds, cocoaand

coffeebeans);

Seeds for propagation;

Bulk stockfeeds.

3 tablets per

7 days when commodity

temperature is above 25°C.

10 days when commodity

temperature is 15° to 25°C.

20 days for surface only ap-

plication to bulk commodi-

ties in well sealed*

structures greater than 375

capacity (e.g. greater

than 300 tonnes wheat).

1-5 days

2 days

10-14 days

13-17 days

23-27 days

Tobacco in bales, cases,

hogsheads in well sealed*

fumigation enclosures

7days

2-3 days

9-10 days

Well-sealed* empty warehouses,

elevators, stores, structures

enclosures and stored beehives,

supers and equipment.

7 days when temperature is

above 25°C.

10 days when temperature

is 15°C to 25°C.

1-5 days

8-12 days

11-15 days

ALUMINUM PHOSPHIDE

UN 1397

HAZCHEM 4WE

IN AN EMERGENCY DIAL: 000

POLICE OR FIRE BRIGADE

IN AN EMERGENCY, SPECIALIST

ADVICE NUFARM AUSTRALIA

LIMITED: 1800 033 498

Capacity of fumigation enclosure

Number tablets

tonnes wheat

bushels

cubic metres

1830

3660

11000

RLP

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Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

THAN YOU tablets

THAN YOU tablets

THAN YOU tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA - U.S. Food and Drug Administration

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Big Penis U.S.A tablets

Big Penis U.S.A tablets

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety