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Food & drugs

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

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

Product safety

Target Recalls Infant Rompers Due to Choking Hazard

30-12-2020

 The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.

Product safety

Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard

30-12-2020

The snaps can break or detach from the suits, posing choking and laceration hazards to children.

Food & drugs

2020 Safety Communications

29-12-2020

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

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Food & drugs

Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems - Lett

07-06-2020

The FDA is reminding reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the ASP...

Food & drugs

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Prov

07-06-2020

The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.

News

Animal Health International Sentenced on Federal Misbranding Charge

05-06-2020

FDA OCI, Colorado, Rx drugs, prescription drugs, veterinary drugs, misbranded drugs, Patterson Companies, NPA, non-prosecution agreement, forfeiture,...

News

Animal Health International Inc. Pleads Guilty to Introduction of Misbranded Drugs into Interstate Commerce

05-06-2020

Animal Health International, Patterson, AHI, Colorado, veterinary prescription drugs, misbranded, Marlin Webb, Billy K. Groce, Hillsville VA

Food & drugs

Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 50

05-06-2020

Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750...

Food & drugs

Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection

05-06-2020

Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex...

Food & drugs

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due

05-06-2020

Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer...

Food & drugs

Transport Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach - Letter to Clinical Laborat

04-06-2020

FDA warns lab staff that exposure to cyanide gas may result from a reaction between transport media and testing platforms that are not compatible.

Food & drugs

Two Neuromuscular Blocking Agents: CDER Alert - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statem

04-06-2020

FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of...

Product safety

Tim Trading Recalls Emori Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poiso

04-06-2020

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act...

Product safety

Capstone Holdings Recalls Simply Earth Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement;

04-06-2020

The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act...

News

Federal Court Issues Temporary Restraining Order against Fort Davis Businessman Offering Fraudulent Coronavirus Cures/Treatment

03-06-2020

FDA OCI, restraining order, temporary, fraudulent, coronavirus, COVID-19, cures, treatments, Ft. Davis TX, Marc Travalino, White Eagle, fraud,...