Children's

Main information

  • Trade name:
  • Children's Fish Oil
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Children's Fish Oil
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216255
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216255

Children's Fish Oil

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Catalent Australia Pty Ltd

Postal Address

PO Box 805,MORDIALLOC, VIC, 3195

Australia

ARTG Start Date

21/10/2013

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No.11

The therapeutic goods grouped in this registration/listing as export only goods under the following names are included in the Australian Register of

Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. Children's Fish Oil

Product Type

Single Medicine Product

Effective date

21/10/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

No Specific Indications included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bulk Container

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1.

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

Opaque Pink round shaped soft capsule

Active Ingredients

natural fish oil

750 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 07:32:37 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

20-3-2019

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus”  Because of Possible Health Risk

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk

Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have...

FDA - U.S. Food and Drug Administration

20-3-2019

Toys"R"Us Canada recalls various Koala Baby 2-Pack Sleepers

Toys"R"Us Canada recalls various Koala Baby 2-Pack Sleepers

Health Canada's sampling and evaluation program has determined that these products do not meet the flammability requirements for children's sleepwear under Canadian law.

Health Canada

18-3-2019

Okaïdi Canada Inc. recalls certain articles of Obaïbi brand sleepwear

Okaïdi Canada Inc. recalls certain articles of Obaïbi brand sleepwear

Health Canada's sampling and evaluation program has determined that these products do not meet the flammability requirements for children's sleepwear under Canadian law.

Health Canada

15-3-2019

Peer review of the pesticide risk assessment of the active substance thiacloprid

Peer review of the pesticide risk assessment of the active substance thiacloprid

Published on: Thu, 14 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiaclopr...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Vêtements Orchestra Canada Inc. recalls girls' two-piece"Puppy Love" pyjama sets and"Hello Weekend" nightgowns

Vêtements Orchestra Canada Inc. recalls girls' two-piece"Puppy Love" pyjama sets and"Hello Weekend" nightgowns

Health Canada has established that the recalled products do not meet the flammability requirements for children's sleepwear under Canadian law.

Health Canada

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Published on: Tue, 12 Mar 2019 An outbreak of 32 Salmonella enterica serotype Poona cases in infants and young children has recently been identified in France (30 cases), Belgium (one case) and Luxembourg (one case). All 32 patients were infected with the same bacterial strain based on core genome multilocus sequence typing analysis. All patients had onset of symptoms between August 2018 and February 2019. Information from interviews was available for 30 patients. All consumed one of three rice-based in...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019

Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk

Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk

Fullei Fresh of Miami, Florida is voluntarily recalling Organic Bean Sprouts because it has the potential to be contaminated with Listeria monocytogenes, 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

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

6-3-2019

Caffeine

Caffeine

Caffeine is a substance naturally present in over 60 different plants, including coffee, kola nut, guarana and yerba maté. It is most commonly consumed in coffee and tea, but it is also found in energy drinks. ANSES recommends that consumers use moderation with regard to caffeine - especially children, pregnant women and individuals who are either sensitive to its effects or who suffer from certain pathologies.

France - Agence Nationale du Médicament Vétérinaire

6-3-2019

Y.M. Inc recalls Urban Kids Girls Graphic Pajama Long Sleeve Shirts

Y.M. Inc recalls Urban Kids Girls Graphic Pajama Long Sleeve Shirts

Health Canada's sampling and evaluation program has determined that these products do not meet the flammability requirements for children's sleepwear under Canadian law.

Health Canada

5-3-2019

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Published on: Fri, 01 Mar 2019 The additive Calsporin® is a preparation of viable spores of Bacillus subtilis DSM 15544, at a minimum declared concentration of 1 × 1010 colony forming units (CFU)/g additive. The additive is authorised as a zootechnical additive (functional group: gut flora stabiliser) for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, laying hens and ornamental fish, dogs, in sows and in suckli...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial proc...

FDA - U.S. Food and Drug Administration

26-2-2019

Pest categorisation of the Ralstonia solanacearum species complex

Pest categorisation of the Ralstonia solanacearum species complex

Published on: Fri, 22 Feb 2019 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of the Ralstonia solanacearum species complex (RSSC), a distinguishable cosmopolitan group of bacterial plant pathogens (including R. solanacearum, Ralstonia pseudosolanacearum and two subspecies of Ralstonia syzygii) of the family Burkholderiaceae. The RSSC causes bacterial wilt in solanaceous crops, such as potato, tomato and pepper, but can also cause wilts i...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk

Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk

Southern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain...

FDA - U.S. Food and Drug Administration

22-2-2019

IKERE Limited recalls ZOOCCHINI UPF50 Baby Cover up

IKERE Limited recalls ZOOCCHINI UPF50 Baby Cover up

As the Baby Cover up is advertised as a bathrobe, it must meet the flammability requirements for children's sleepwear. This product fails to meet these requirements. As a beach robe / cover-up it is not subject to the Children Sleepwear Regulations.

Health Canada

18-2-2019

Health Canada recommends that children and youth not use cough and cold products that contain opioids

Health Canada recommends that children and youth not use cough and cold products that contain opioids

OTTAWA - The Government of Canada is committed to better informing Canadians about the risks of health products that contain opioids. Following a safety review of cough and cold products containing opioids, Health Canada is advising that Canadian children and adolescents (under 18 years of age) should not use cough and cold products containing codeine, hydrocodone and normethadone, as a precautionary measure.

Health Canada

16-2-2019

Smoked Alaska Seafoods, Inc. Recalls 6.5 oz Jars & Cans of Smoked Silver Salmon Because of Possible Health Risk

Smoked Alaska Seafoods, Inc. Recalls 6.5 oz Jars & Cans of Smoked Silver Salmon Because of Possible Health Risk

Smoked Alaska Seafoods, Inc. of Wasilla, AK is recalling all jars and cans of Smoked Silver Salmon in 6.5 oz. containers with the production code of AL81111133 on the bottom of the jar/can because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

FDA - U.S. Food and Drug Administration

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-2-2019

Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

Published on: Thu, 14 Feb 2019 Following the submission of application EFSA‐GMO‐RX‐012 under Regulation (EC) No1829/2003 from BayerCropScienceN.V., the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified oilseed rape T45, for food and feed uses, excluding cultivation within the European Unio...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-2-2019

Kyte BABY LLC recalls Kyte BABY Sleep Bag Walkers

Kyte BABY LLC recalls Kyte BABY Sleep Bag Walkers

The sleep bag with ankle cuffs fails to meet the flammability requirements for children's sleepwear under Canadian Law, therefore posing a risk of burn injuries to children.

Health Canada

5-2-2019

RH recalls Metal-Wrapped Coffee Tables

RH recalls Metal-Wrapped Coffee Tables

The plating beneath the surface coating may contain lead and may present a risk of lead exposure to children. Lead is toxic if ingested and can cause adverse health effects.

Health Canada

4-2-2019

Gris Souris Accessoires recalls Pacifier Clips

Gris Souris Accessoires recalls Pacifier Clips

While opening and closing, the metal clip can break, releasing small parts that may pose a choking hazard to young children.

Health Canada

29-1-2019

CannTrust recalls one lot of Liiv THC Cannabis Oil

CannTrust recalls one lot of Liiv THC Cannabis Oil

The outside box may be incorrectly labelled as “Liiv CBD Cannabis Oil” with corresponding CBD potency information. The immediate containers of the product is correctly labelled as THC Cannabis Oil. The product was sold as THC cannabis oil.

Health Canada

28-1-2019

Public Notification: Natural V=GRA contains hidden drug ingredients

Public Notification: Natural V=GRA contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Natural V=GRA, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

Jac. Vandenberg, Inc. Recalls Fresh Peaches, Fresh Nectarines and Fresh Plums Because They May Be Contaminted with Listeria Monocytogenes

Jac. Vandenberg, Inc. Recalls Fresh Peaches, Fresh Nectarines and Fresh Plums Because They May Be Contaminted with Listeria Monocytogenes

Jac. Vandenberg, Inc. of Yonkers, New York is recalling 1,727 cartons of Fresh Peaches, 1,207 cartons of Fresh Nectarines and 365 cartons of Fresh Plums because they have the potential to be contaminated with Listeria monocytogenes, 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

24-1-2019

Unauthorized Panasilver product for children and adults may pose serious health risk

Unauthorized Panasilver product for children and adults may pose serious health risk

Health Canada is advising Canadians that Panasilver, a product distributed by Activation Products Canada Inc., in Cobourg, Ontario, is not authorized for sale and may pose serious health risks.

Health Canada

24-1-2019

Product Recall Because of Possible Health Risk

Product Recall Because of Possible Health Risk

Satur Farms, 3705 Alvah's Lane, Cutchogue, NY 11935 is voluntarily recalling Baby Spinach and Mesclun with the specific lot numbers listed below 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. 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

19-1-2019

Data sources on animal diseases: Country Card of Spain

Data sources on animal diseases: Country Card of Spain

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Midwest-CBK recalls Midwest Gift brand Baby Rattle Socks

Midwest-CBK recalls Midwest Gift brand Baby Rattle Socks

The small adornments on the socks may detach which could pose as a choking hazard for young children.

Health Canada

3-1-2019

Dollarama recalls MONTOY Little Princess Doll

Dollarama recalls MONTOY Little Princess Doll

The plastic doll contains levels of phthalates that exceed the allowable limit and may pose a chemical hazard. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

2-1-2019

Oskri Organics Corporation Recalls Oskri Organic Sunflower Butter Lot #099, Oskri Tahini Butter Lot #193 and Thrive Sunflower Butter Lot  #233 Because of Possible Health Risk

Oskri Organics Corporation Recalls Oskri Organic Sunflower Butter Lot #099, Oskri Tahini Butter Lot #193 and Thrive Sunflower Butter Lot #233 Because of Possible Health Risk

Oskri Organics Corporation of Lake Mills, WI is recalling Oskri Organic Sunflower Butter Lot # 099, Oskri Tahini Butter LOT # 193 and Thrive Sunflower Butter LOT # 233, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffnes...

FDA - U.S. Food and Drug Administration

1-1-2019

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classifi...

FDA - U.S. Food and Drug Administration

27-12-2018

Reliance Products Ltd. Recalls Bio-Green Digester, Bio-Blue Fluid and Bio-Blue Toilet Deodorant

Reliance Products Ltd. Recalls Bio-Green Digester, Bio-Blue Fluid and Bio-Blue Toilet Deodorant

Health Canada has determined that the recalled product does not meet the chemical hazard labelling and child-resistant packaging for consumer products as set out in the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

26-12-2018

Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls

Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls

Apio Inc. of Guadalupe, California is expanding a voluntary recall of Eat Smart Salad Shake Ups single-serve bowls. The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that another random sample of Eat Smart Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. single-serve bowls (5.5oz) with Best Before Date of Dec 29, 2018, Lot 112 346, tested positive for Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail ...

FDA - U.S. Food and Drug Administration

24-12-2018

Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk

Columbia River Natural Pet Foods Inc. Voluntarily Expands Recall to Include Cow Pie and Chicken & Vegetables Fresh Frozen Meats for Dogs and Cats Due to Possible Health Risk

Columbia River Natural Pet Foods of Vancouver, WA is voluntarily expanding their current recall to include additional products: 261 packages of Cow Pie Lot # 72618 and 82 packages of Chicken & Vegetables Lot# 111518 fresh frozen meats for dogs and cats, produced in July 2018 and November 2018, due to their potential to be contaminated with Salmonella and Listeria monocytogenes

FDA - U.S. Food and Drug Administration

20-12-2018

Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk

Inspired Organics Issues Voluntary Recall of Organic Nut & Seed Butters Due to Potential Health Risk

Inspired Organics, LLC has issued a voluntary recall of Organic Almond, Peanut, and Tahini Butters due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short- term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can...

FDA - U.S. Food and Drug Administration

20-12-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinog...

FDA - U.S. Food and Drug Administration

20-12-2018

FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.

FDA - U.S. Food and Drug Administration

20-12-2018

Button batteries: prevent their ingestion by young children and adopt the right reflexes in the event of an accident

Button batteries: prevent their ingestion by young children and adopt the right reflexes in the event of an accident

In view of the numerous cases of very young children(usually under the age of 6) ingesting button batteries, with serious and sometimes fatal consequences, the health authorities are once again alerting parents, carers and health professionals to this little-known health risk and making them aware of the immediate steps to take in the event of an accident.

France - Agence Nationale du Médicament Vétérinaire

20-12-2018

Loblaw Companies Limited recalls Joe Fresh Baby Girls' Running Shoe

Loblaw Companies Limited recalls Joe Fresh Baby Girls' Running Shoe

The hook and loop fastener on the shoe may detach which could pose as a choking hazard for young children.

Health Canada

20-12-2018

Navien Inc. recalls Propane Conversion Kit for Condensing Tankless Water Heater and Combination Boiler

Navien Inc. recalls Propane Conversion Kit for Condensing Tankless Water Heater and Combination Boiler

Navien has identified a non-conforming specification in the natural gas (NG) to propane gas (LP) conversion kit that is supplied as an accessory with each unit. If the kit is installed in order to use propane gas rather than natural gas to fuel the unit, and if not properly vented, it could pose a risk of exposure to carbon monoxide.

Health Canada

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Gymnosporangium spp. (non‐EU)

Pest categorisation of Gymnosporangium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Gymnosporangium spp. (non‐EU), a well‐defined and distinguishable group of fungal plant pathogens of the family Pucciniaceae affecting woody species. Many different Gymnosporangium species are recognised, of which at least 14 species are considered not to be native in the European Union. All the non‐EU Gymnosporangium species are not known to be present in th...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Grapholita inopinata

Pest categorisation of Grapholita inopinata

Published on: Wed, 19 Dec 2018 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Grapholita inopinata, (Lepidoptera: Tortricidae), the Manchurian fruit moth, for the territory of the EU. G. inopinata is a well‐defined species that is recognised as a major pest of Malus spp. in Far East Russia, Eastern Siberia and northern China. G. inopinata is less common in Japan where it is not a serious pest. G. inopinata is not known to occur in the EU. G. inopinata is listed in Annex IIAI of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Cronartium spp. (non‐EU)

Pest categorisation of Cronartium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower

Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called He...

FDA - U.S. Food and Drug Administration

19-12-2018

CLS Sales Inc. recalls Wood Pull Back Plane

CLS Sales Inc. recalls Wood Pull Back Plane

Health Canada's sampling and evaluation program has determined that this toy does not meet the Canadian safety requirements for toys. More specifically, the tail fin and/or propeller may break off the toy, posing a choking hazard to young children.

Health Canada

19-12-2018

The Manhattan Toy Company recalls "Find the Bear" Soft Books

The Manhattan Toy Company recalls "Find the Bear" Soft Books

A metal grommet used to attach a fabric flap to a page in the book may pull apart posing a small parts choking hazard for small children.

Health Canada

19-12-2018

Pest categorisation of Phyllosticta solitaria

Pest categorisation of Phyllosticta solitaria

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Pest categorisation of Grapholita prunivora

Pest categorisation of Grapholita prunivora

Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Princess Auto Ltd. Recalls Valley Sportsman 9.5 Litre Propane Fish Fryer

Princess Auto Ltd. Recalls Valley Sportsman 9.5 Litre Propane Fish Fryer

There is a small hole near the handle which could allow hot cooking oil to drip from the pan, posing a burn hazard to consumers.

Health Canada

18-12-2018

The Children's Place recalls NewbornRosebud, Sophy White Floral, and Ladybug Jazzberry Snowsuits

The Children's Place recalls NewbornRosebud, Sophy White Floral, and Ladybug Jazzberry Snowsuits

Metal snaps on the products may loosen and detach creating a choking hazard.

Health Canada

18-12-2018

Pest categorisation of Carposina sasakii

Pest categorisation of Carposina sasakii

Published on: Mon, 17 Dec 2018 The EFSA Panel on Plant Health performed a pest categorisation of the peach fruit moth, Carposina sasakii Matsumura (Lepidoptera: Carposinidae) for the EU. C. sasakii is not currently regulated in the EU although C. niponensis, a valid species of no economic significance that was previously mistakenly synonymised with C. sasakii, is regulated in Annex IIAI of 2000/29 EC. C. sasakii is a well‐defined species that is recognised as a major pest of apples, peaches and pears in...

Europe - EFSA - European Food Safety Authority Publications

19-3-2019

Always keep medicines out of reach of children! https://twitter.com/HHSGov/status/1107674662534815744 …

Always keep medicines out of reach of children! https://twitter.com/HHSGov/status/1107674662534815744 …

Always keep medicines out of reach of children! https://twitter.com/HHSGov/status/1107674662534815744 …

FDA - U.S. Food and Drug Administration

18-3-2019

Over 300 children in the United States are treated for poisoning each day. Keep your kids safe by keeping toxic products and medicines out of reach:  http://bit.ly/2Y7fVA2  #PPW2019 #MondayThoughtspic.twitter.com/wchq0dVW5r

Over 300 children in the United States are treated for poisoning each day. Keep your kids safe by keeping toxic products and medicines out of reach: http://bit.ly/2Y7fVA2  #PPW2019 #MondayThoughtspic.twitter.com/wchq0dVW5r

Over 300 children in the United States are treated for poisoning each day. Keep your kids safe by keeping toxic products and medicines out of reach: http://bit.ly/2Y7fVA2  #PPW2019 #MondayThoughts pic.twitter.com/wchq0dVW5r

FDA - U.S. Food and Drug Administration

22-2-2019

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children.  http://go.usa.gov/cpygz  #NIHChat

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children. http://go.usa.gov/cpygz  #NIHChat

A5: #FDA funds $6M/yr for the Pediatric Device Consortia Grants Program – a program to provide advice and support services to advance innovation in medical devices for children. http://go.usa.gov/cpygz  #NIHChat

FDA - U.S. Food and Drug Administration

28-1-2019


Benzyl nicotinate / camphor / dimethyl sulfoxide / nonivamide / turpentine oil: List of nationally authorised medicinal products - PSUSA/00010584/20180

Benzyl nicotinate / camphor / dimethyl sulfoxide / nonivamide / turpentine oil: List of nationally authorised medicinal products - PSUSA/00010584/20180

Benzyl nicotinate / camphor / dimethyl sulfoxide / nonivamide / turpentine oil: List of nationally authorised medicinal products - PSUSA/00010584/20180

Europe - EMA - European Medicines Agency

21-1-2019

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

Recall - potential risk of harm for children who access the button battery

Therapeutic Goods Administration - Australia