Food & drugs

CBER FY 2018 Recall Postings

02-10-2019

List of CBER FY 2018 Recall Postings.

CBER FY 2019 Recall Postings

02-10-2019

Listing of CBER FY 2019 Recall Postings

2019 Safety Communications

01-10-2019

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certa

01-10-2019

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication

Dorset Cheese Voluntarily Recalled by North Atlantic and Northeast Whole Foods Market Stores Due to Possible Health Risk

01-10-2019

In response to a recall from Consider Bardwell Farm, Whole Foods Market stores in the Northeast and North Atlantic regions are voluntarily recalling Dorset cheese because of a potential contamination of Listeria monocytogenes

Cellect Products Inc. and Oglethorpe Ltd. Issue Voluntary Worldwide Recall of Cellect Unflavored Powder & Essentials Factor Cel

30-09-2019

The Cellect Unflavored Powder & Essentials Factor Cell Synergy Unflavored Powder has been found to have unsafe levels of Arsenic and Lead.

Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single Use Cups

26-09-2019

Mavidon is voluntarily recalling 21 lots of LemonPrep® 4 ounce tubes and single use cups to user level. These products have been found to be contaminated with Burkholderia cepacia. The specific lots are listed below:

Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the po

25-09-2019

Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some...

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpect

23-09-2019

– Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by...

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Po

19-09-2019

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity.

Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconne

17-09-2019

FDA has classified the voluntary action as a Class I recall for the Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit

Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLE

16-09-2019

Fitoterapia USA Inc., is voluntarily recalling 19,000 bottles of MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with Tadalafil....

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Food & drugs

CBER FY 2018 Recall Postings

CBER FY 2019 Recall Postings

2019 Safety Communications

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certa

Dorset Cheese Voluntarily Recalled by North Atlantic and Northeast Whole Foods Market Stores Due to Possible Health Risk

Cellect Products Inc. and Oglethorpe Ltd. Issue Voluntary Worldwide Recall of Cellect Unflavored Powder & Essentials Factor Cel

Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single Use Cups

Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the po

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpect

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Po

Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconne

Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLE

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UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

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