METHAM

Main information

  • Trade name:
  • NUFARM METHAM SOIL FUMIGANT
  • Pharmaceutical form:
  • Soluble
  • Units in package:
  • 20L,200L,985L,1000L,1200L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical

Documents

Localization

  • Available in:
  • NUFARM METHAM SOIL FUMIGANT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BULK POTTING SOIL | FIELD APPLICATION TO BEDS OR ROWS | FIELD APPLICATION TO TOTAL AREA | LAWN | SEEDBED | TOBACCO - PRIOR TO SO
  • Therapeutic area:
  • soil fumigant
  • Therapeutic indications:
  • FUNGAL DISEASES - SEE LABEL | NEMATODE - SOIL BORNE PLANT PARASITIC | ONION WEED | SYMPHYLID | WEED SEED - SEE LABEL | ASPHODEL | CLUB ROOT OF CRUCIFERS | FAT HEN | FUSARIUM | GARDEN CENTIPEDES | ONION GRASS | PHYTOPHTHORA | PRINCE OF WALES FEATHER | PYTHIUM | RHIZOCTONIA | SCLEROTINIA | SYMPHYLANS | VERTICILLIUM | WEED SEEDS | WILD ONION | WINTER GRASS
  • Product summary:
  • Pre-planting treatment for control of soil-borne pests.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 34049/57948
  • Authorization date:
  • 05-07-2013
  • Last update:
  • 15-06-2017

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

,Nufarm

Metham

Soil

Fumigant

Draft:

3

October

2012

Label

Page

'"

POISON

Nufarm

KEEP

OUT

OF

REACH

OF

CHILDREN

READ

SAFETY

DIRECTIONS

BEFORE

OPENING

OR

USING

Nufarm

Australia

Limited

103-105

Pipe

Road

Laverton

North

Victoria

3026

Tel:

(03)

92821000

Fax:

(03)

9282

1001

GENERAL

INSTRUCTIONS

Nufarm

Metham

Soil

Fumigant

Contents:

Litres

Litres

Litres

1000

Litres

1200

Litres

PROTECTION

OF

WILDLIFE,

FISH,

CRUSTACEANS

AND

ENVIRONMENT

contaminate

streams,

rivers

waterways

with

chemical

used

containers.

STORAGE

AND

DISPOSAL

APVMA

Approval

No.:

34049/57948

RLP

Approved

Store

closed,

original

container

dry,

cool,

well

ventilated

area,

direct

sunlight.

Store

safe

place

away

from

foodstuffs,

seeds

fertilisers.

repack

container

other

purposes.

Triple

preferably

pressure

rinse

containers

before

disposal.

rinsings

spray

tank.

dispose

undiluted

chemicals

site.

SAFETY

DIRECTIONS

Harmful

inhaled

swallowed.

Poisonous

inhaled.

Will

damage

eyes,

nose

throat

skin.

Repeated

exposure

cause

allergic

disorders.

Interacts

with

alcohol

-avoid

alcohol

day(s)

use.

inhale

vapour

spray

mist.

fumes

first

cause

smarting,

then

watering

eyes.

This

should

taken

warning

sign.

liquid

cause

burns.

store

well

ventilated

areas.

When

opening

container

preparing

product

use,

wear

chemical

resistant

clothing

buttoned

neck

wrist,

washable

hat,

elbow-length

chemical

resistant

gloves,

chemical

resistant

footwear,

full

face-piece

respirator

with

organic

vapour/gas

cartridge

canister

goggles

half

face-piece

respirator

with

organic

vapour

cartridge

canister].

When

using

prepared

(spray)

(foam)

wear

cotton

overalls

buttoned

neck

wrist,

washable

hat,

elbow-length

chemical

resistant

gloves,

chemical

resistant

footwear,

full

face-piece

respirator

with

organic

vapour/gas

cartridge

canister

goggles

half

face-piece

respirator

with

organic

vapour

cartridge

canister].

clothing

becomes

contaminated

with

product

with

spray,

remove

clothing

immediately.

product

vapour

skin,

immediately

wash

area

with

soap

water.

product

vapour

eyes,

wash

immediately

with

water.

After

before

eating,

drinking

smoking,

wash

hands,

arms

face

thoroughly

with

soap

water.

After

each

day's

use,

wash

gloves,

goggles,

respirator

rubber

wash

with

detergent

warm

water

contaminated

clothing.

re-use

footwear

until

thoroughly

aired.

FIRST

AID

poisoning

occurs,

contact

Doctor

Poisons

Information

Centre

(Phone

26).

Zealand

0800

766.

Avoid

giving

alcohol.

skin

contact

occurs,

remove

contaminated

clothing

wash

skin

thoroughly.

eyes,

hold

eyes

open,

flood

with

water

least

minutes

doctor.

MATERIAL

SAFETY

DATA

SHEET

further

information

refer

Material

Safety

Data

Sheet

(MSDS)

Fact

Sheet

available

from

registrant

Nufarm

Limited

point

sale.

-----------------

Nufarm

Metham

Soil

Fumigant

Draft:

3

October

2012

In

case

of

emergency:

Phone

1800

033

498

shift

supervisor.

Toll

free

hours

CONDITIONS

OF

SALE

Page2

"Any

provisions

rights

under

Competition

Consumer

2010

relevant

state

legislation

which

cannot

excluded

those

statutes

intended

excluded

these

conditions

sale.

Subject

foregoing,

warranties,

conditions,

rights

remedies,

expressed

implied

under

common

law,

statute

otherwise,

relation

sale,

supply,

application

this

product,

excluded.

Nufarm

Australia

Limited

and/or

affiliates

("Nufarm")

shall

accept

liability

whatsoever

(including

consequential

loss),

howsoever

arising

(including

negligence)

damage,

injury

death

connected

with

sale,

supply,

application

this

product

except

liability

which

cannot

excluded

statute."

CORROSIVE,

LIQUID,

BASIC,

ORGANIC

N.O.S.

(CONTAINS

MET

HAM

AS

SODIUM

SALT)

UN

No:

3267

PACKING

GROUP:

Ill

HAZCHEM:

2X

IN

AN

EMERGENCY

DIAL:

000

POLICE

OR

FIRE

BRIGADE

IN

AN

EMERGENCY,

SPECIALIST

ADVICE

NUFARM

AUSTRALIA

LIMITED

1800

033

498

Barcode

drumMUSTER

logo

t

I"

POISON

Mufarm

KEEP

OUT

OF

REACH

OF

CHILDREN

READ

SAFETY

DIRECTIONS

BEFORE

OPENING

OR

USING

Nufarm

Metham

Soil

Fumigant

ACl]VE

CQNSTITUENT:·423g/L

METHAM

present

as

the

sodium

salt

"'"

'-.·

···"

-·.-

.·.·

,.,__.,

DIRECTIONS

FOR

USE

RESTRAINTS

apply

soil.

exceed

specified

rates.

high

winds.

apply

humidity

when

temperature

above

32°C

SITUATION·

PEST

STATE

RATE

CONTROLLED

Sites

seedbeds,

Germinating

Weed

States

25-50U50L

water

Lawns

&

other

Seeds

including

1000

limited

areas

··'

Winter

grass,

Prince

Wales

Feather,

Hen,

Nematodes,

1.1L

/12L

water

Symphylids

(Not

Field:

Application

Tas.)

(Garden

NSW,Qid,

250-500U400-700L

Total

Area

Centipede),

Vic,

water

Fungus

Diseases

only

including

250-500Uha

Rhizoctonia,

(undiluted)

Pythium,

250-500L

/400-?00L

Fusarium,

perha

Phytophthora,

Verticillium,

250-500Uha

Sclerotinia

(undiluted)

Field:

Application

Club

Root

States

250-500U400-700L

Beds

Rows

Crucifers

water

250-500Uha

(undiluted)

400-BOOU?00-1

OOOL

water

perha

400-BOOUha

(undiluted)

250-500L

/400-?00L

water

250-500Uha

(undiluted)

CRITICAL

COMMENTS

SOIL

INJECTIONS:

higher

rate

heavier

soils.

Injection

points

injection

nozzles

under

blade

should

12cm

apart,

15cm

deep

well

prepared

moist

soil.

I!T]mediately

after

injection,

compact

soil

rolling.

Water

lightly

prevent

escape

gas.

Repeat

irrigation

after

days

light

soils

soils

which

crack

quickly.

Prevent

run-off.

ROTARY

TILLER:

Spray

front

tiller.

Roll

immediately

compact

soil.

Lightly

water

above.

SOIL

INJECTION:

higher

rate

heavier

soils.

Follow

method

injection

described

under

seedbeds.

ROTARY

TILLER:

Spray

front

tiller.

Roll

immediately

compact

soil.

Irrigate

once

with

enough

water

seal

soil

surface.

Repeat

irrigation

after

days

light

soils

soils

that

crack

quickly.

SOIL

INJECTION:

higher

rate

heavier

soils.

Solution

injected

into

pre-formed

beds

band

treatment.

Follow

instructions

injection

above.

wider

treated

band

space

more

injection

points

intervals

12cm

apart.

methods

should

depth

0-15cm.

BEDS-

SOIL

COVERING

METHOD:

higher

rate

heavier

soils.

Inject

drip

into

moist

soil

directly

ahead

shaper.

sufficient

water

ensure

uniform

application.

Cover

with

-15cm

moist

soil.

Immediately

roll

compact

soil.

ROTARY

TILLER:

Spray

front

tiller.

Roll

immediately

compact

soil.

Irrigate

once

with

enough

water

seal

soil

surface.

Repeat

irrigation

after

days

light

soils

that

crack

quickly.

Nufarm

Metham

Soil

Fumigant

Draft:

October

2012

Page

SITUATION

PEST

STATE

RATE

CRITICAL

COMMENTS

CONTROLLED

Field:

Application

Germinating

Weed

only

250-BOOUtreated

TRICKLE

IRRIGATION:

higher

rate

heavier

soils.

Rows

Seeds

including

weeks

prior

planting

soil

must

bed-formed

with

tric

tape

Winter

grass,

plastic

mulch

Thoroughly

soil

allow

weed

seed

germinate.

Prince

Wales

Apply

Metham

moist

soil

injecting

into

mainline

using

suitable

Feather

pump

sufficient

entire

root

zone.

longer

injection

period

heavier

soils.

Flush

lines

equipment

with

clean

water

after

Nematodes,

use.

Puncture

plastic

weeks

after

treatment

allow

dissipation

Symphylids

(Not

Metham.

Heavy

nematode

infestation

require

further

treatment

(Garden

prior

second

crop.

ENSURE

INJECTION

CAPACITY

Centipede),

HANDLE

LARGE

RATES

SPILT

APPLICATIONS.

Potting

Soil

Fungus

Diseases

States

600mUm3

soil

CEMENT

MIXER:

moist

soil

thoroughly

adding

Metham

lidded

including

mixer

well

ventilated

area.

Empty

soil

into

pile

cover

with

Rhizoctonia,

plastic

sheeting

keep

gas.

Pythium,

1.1L/12L

water

ROTARY

TILLER

METHOD:

Spread

soil

smooth

more

than

Fusarium,

depth

20cm.

Apply

Metham

over

entire

surface

till

maximum

Phytophthora,

adjustable

depth

tiller.

Treat

further

layers

necessary

seal

Verticillium,

layer

with

water.

Tobacco

Plant

Sclerotinia

Qld,

9.75L/700-900L

water

TOBACCO

SEED

higher

rate

heavi

soils.

Apply

Club

Root

only

100m

Autumn

through

approved

irrigation

system,

sprayers

Crucifers

suitable

approved

equipment.

Follow

instructions

seedbeds

plant

beds.

treat

tobacco

plant

beds

hand

directed

methods

Onion

Weed

only

U50L

water

SPOT

TREATMENT:

Spray

entire

surface

area

using

drenching

nozzles

NOT

TO

BE

USED

FOR

ANY

PURPOSE

OR

IN

ANY

MANNER

CONTRARY

TO

THIS

LABEL

UNLESS

AUTHORISED

UNDER

APPROPRIATE

LEGISLATION.

PROHIBITIONS

HAND

DIRECTED

SPRAYING

INCLUDING

SPRINKLER

CAN.

TREAT

POTTING

SOIL

LOOSE

MIXED

METHOD

SHREDDER.

FLOOD

IRRIGATION

OVERHEAD

SPRINKLER

SYSTEMS.

GENERAL

INSTRUCTIONS

Mixing

with

water

apply

immediately

allow

mixture

stand

rnight.

Application

Soil

should

carefully

prepared

advance

according

directions

Cultivate

area

thoroughly

break

clods.

Loosen

soil

deeply

week

advance

application.

Soil

should

kept

moist

until

application,

soil

crusted

meantime,

re-cultivate

lightly.

Soil

temperature

should

range

0°C-32°C

depth

Scm.

Where

fumes

become

unpleasant

spray

with

water

seal

fumes

INTERVALS

CULTIVATION

&

PLANTING

AFTER

APPLICATION

Planting

take

place

14-21

days

after

application

soil

light-medium

texture

excessively

cold.

minimum

interval

days

necessary

where

soil

texture

heavy,

high

organic

matter,

soil

temperature

less

than

15°C.

interval

required

application

rate

greater

than

1100L/ha.

Cultivation

should

carried

wet,

heavy

soils

prevent

crusting

promote

drying

days

after

pplication

repeated

when

necessary

treated

soils

with

untreated

soils.

indicator

crop

test

that

NUFARM

remains

soil,

approximately

days

before

main

crop.

Lettuce

radish

suitable

this

purpose

because

their

rapid

germination

process.

Check

root

damage

which

will

indicate

whether

soil

still

toxic

POTTING

SOIL

potting

soil

heavy

field

soil,

including

soils

high

clay

organic

matter,

ensure

that

proper

aeration

drying

soil

takes

place.

PRECAUTIONS

Workers

previously

experiencing

skin

respiratory

tract

irritation

from

metham-sodium

exposure

should

work

with

metham-sodium

products.

Afte

mixing

with

water

allow

stand

poisonous

fumes

released

standing.

Workers

manually

sealing

should

wear

personal

protective

clothing

specified

applicators.

RE-ENTRY

PERIOD-

FIELD

allow

entry

into

treated

areas

hours

When

prior

entry

necessary

personal

protective

equipment

specified

applicators.

Clothing

must

laundered

after

each

day's

RE-ENTRY

PERIOD-

GREENHOUSE

APPLICATION,

INCLUDING

UNDER

PLASTIC

allow

entry

into

treated

areas

days.

When

prior

entry

necessary

wear

personal

protective

equipment

specified

applicators.

Clothing

must

laundered

after

each

Thoroughly

ventilate

greenhouse

hours

after

removing

plastic.

RE-ENTRY

PERIOD

POTTING

SOIL

Treated

soil

remain

covered

plastic

sheeting

similar

material

impermeable

MITC,

days

after

treatment.

When

prior

handling

necessary,

wear

personal

protective

equipment

specified

applicators.

Clothing

must

laundered

after

each

WARNING

STATEMENTS

warning

statements

required

Nufarm

Metham

Soil

Fumigant

Draft:

3

October

2012

Page

3

PROTECTION

OF

CROPS,

NATIVE

&

OTHER

NON-TARGET

PLANTS

spray

desirable

plants

lawns

avoid

spray

drift.

apply

within

metre

drip

line

plants.

green

houses

where

plants

present.

apply

under

weather

conditions

from

spraying

equipment,

that

cause

spray

drift

onto

nearby

susceptible

plants/crops,

cropping

lands

pastures.

PROTECTION

OF

WILDLIFE,

FISH,

CRUSTACEA

AND

ENVIRONMENT

contaminate

streams,

rivers

waterways

with

chemical

used

containers.

STORAGE

AND

DISPOSAL

Store

closed,

original

container

dry,

cool,

well

ventilated

area,

direct

sunlight.

Store

safe

place

away

from

foodstuffs,

seeds

fertilisers.

repack

container

other

purposes.

Triple

preferably

pressure

rinse

containers

before

disposal.

rinsings

spray

tank.

dispose

undiluted

chemicals

site.

SAFETY

DIRECTIONS

Harmful

inhaled

swallowed.

Poisonous

inhaled.

Will

damage

eyes,

nose

throat

skin.

Repeated

exposure

cause

allergic

disorders.

Interacts

with

alcohol-

avoid

alcohol

day(s)

use.

inhale

vapour

spray

mist.

fumes

first

cause

smarting,

then

watering

eyes.

This

should

taken

warning

sign.

liquid

cause

burns.

store

well

ventilated

areas.

When

opening

container

preparing

product

use,

wear

chemical

resistant

clothing

buttoned

neck

wrist,

washable

hat,

elbow-length

chemical

resistant

gloves,

chemical

resistant

footwear,

full

face-piece

respirator

with

organic

vapour/gas

cartridge

canister

goggles

half

face-piece

respirator

with

organic

vapour

cartridge

canister].

When

using

prepared

(spray)

(foam)

wear

cotton

overalls

buttoned

neck

wrist,

washable

hat,

elbow-length

chemical

resistant

gloves,

chemical

resistant

footwear,

full

face-piece

respirator

with

organic

vapour/gas

cartridge

canister

goggles

half

face-piece

respirator

with

organic

vapour

cartridge

canister].

clothing

becomes

contaminated

with

product

with

spray,

remove

clothing

immediately.

product

vapour

skin,

immediately

wash

area

with

soap

water.

product

vapour

eyes,

wash

immediately

with

water.

After

before

eating,

drinking

smoking,

wash

hands,

arms

face

thoroughly

with

soap

water.

After

each

day's

use,

wash

gloves,

goggles,

respirator

rubber

wash

with

detergent

warm

water

contaminated

clothing.

re-use

footwear

until

thoroughly

aired.

FIRST

AID

poisoning

occurs,

contact

Doctor

Poisons

Information

Centre

(Phone

1311

26).

Zealand

0800

766.

Avoid

giving

alcohol.

skin

contact

occurs,

remove

contaminated

clothing

wash

skin

thoroughly.

eyes,

hold

eyes

open,

flood

with

water

least

minutes

doctor.

MATERIAL

SAFETY

DATA

SHEET

additional

information

refer

Material

Safety

Data

Sheet

Fact

Sheets

available

from

registrant

Nufarm

Australia

Limited

point

sale.

In

case

of

emergency:

Phone

1800

033

498

shift

supervisor.

Toll

free

hours.

CONDITIONS

OF

SALE

"Any

provisions

rights

under

Competition

Consumer

2010

relevant

state

legislation

which

cannot

excluded

those

statutes

intended

excluded

these

conditions

sale.

Subject

foregoing,

warranties,

conditions,

rights

remedies,

expressed

implied

under

common

law,

statute

otherwise,

relation

sale,

supply,

application

this

product,

excluded.

Nufarm

Australia

Limited

and/or

affiliates

("Nufarm")

shall

accept

liability

whatsoever

(including

consequential

loss),

howsoever

arising

(including

negligence)

damage,

injury

death

connected

with

sale,

supply,

application

this

product

except

liability

which

cannot

excluded

statute."

Nufarm

Australia

Limited

03-1

Pipe

Road

Laverton

North

Victoria

3026

Tel:

(03)

9282

1000

Fax:

(03)

92821001

CORROSIVE,

LIQUID,

BASIC,

ORGANIC

N.O.S.

(CONTAINS

MET

HAM

AS

SODIUM

SALT}

UN

No:

3267

PACKING

GROUP:

Ill

HAZCHEM:

2X

IN

AN

EMERGENCY

DIAL:

000

POLICE

OR

FIRE

BRIGADE

IN

AN

EMERGENCY,

SPECIALIST

ADVICE

NUFARM

AUSTRALIA

LIMITED

1800

033

498

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 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 vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-12-2018

Moonstruck Chocolate Co. Issues Allergy Alert On Undeclared Hazelnuts In 4 Oz. Sea Salt Caramels Tumbled In Milk Chocolate

Moonstruck Chocolate Co. Issues Allergy Alert On Undeclared Hazelnuts In 4 Oz. Sea Salt Caramels Tumbled In Milk Chocolate

Moonstruck Chocolate Company of Portland, Oregon is recalling 600/4 oz. bags of Sea Salt Caramels Tumbled In Milk Chocolate, because it may contain undeclared hazelnuts. People who have an allergy or severe sensitivity to hazelnuts run the risk of a serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads

Tres Hermanos Bakery Issues Allergy Alert on Undeclared Milk in Telera and Bolillo Breads

Tres Hermanos Bakery of Wyoming, MI is recalling its white Telera and Bolillo Mexican salt breads because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

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

2-11-2018

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

FDA - U.S. Food and Drug Administration

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA - U.S. Food and Drug Administration

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

8-9-2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

20-12-2018


Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018

Poteligeo (Kyowa Kirin Holdings B.V.)

Poteligeo (Kyowa Kirin Holdings B.V.)

Poteligeo (Active substance: Mogamulizumab) - Centralised - Authorisation - Commission Decision (2018) 7975 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4232

Europe -DG Health and Food Safety

24-9-2018

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Tetraphase Pharmaceuticals Ireland Limited)

Xerava (Active substance: Eravacycline) - Centralised - Authorisation - Commission Decision (2018)6231 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4237

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

7-8-2018

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Active substance: Ribavirin ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5423 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1185/T/29

Europe -DG Health and Food Safety

11-7-2018

MAVENCLAD (Merck Europe B.V.)

MAVENCLAD (Merck Europe B.V.)

MAVENCLAD (Active substance: cladribine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4512 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4230/T/4

Europe -DG Health and Food Safety

3-7-2018

Edistride (AstraZeneca AB)

Edistride (AstraZeneca AB)

Edistride (Active substance: dapagliflozin) - Centralised - Yearly update - Commission Decision (2018)4237 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Rezolsta (Janssen-Cilag International NV)

Rezolsta (Janssen-Cilag International NV)

Rezolsta (Active substance: Darunavir/Cobicistat) - Centralised - 2-Monthly update - Commission Decision (2018) 4239 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2819/WS/1312

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety