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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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News

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

11-06-2020

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

News

Chinese Manufacturer Charged with Exporting Misbranded and Defective Masks Falsely Purporting to be N95 Respirators

11-06-2020

Chinese, manufacturer, charged, exporting, misbranded, defective masks, N95 respirators, false, mislabeled, first responders, healthcare workers,...

Food & drugs

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets

11-06-2020

Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg,...

Food & drugs

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets

11-06-2020

Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg,...

Product safety

Davina Wellness Recalls Wintergreen Essential Oil and Essential Oil Blend with Wintergreen Due to Failure to Meet Child Resista

11-06-2020

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

Product safety

Bonnsu Recalls Miniware Teething Spoons Due to Choking Hazard

11-06-2020

The teething spoon can break in a child’s mouth when being used as a teether, posing a choking hazard to infants.

Product safety

Ushio America Recalls Indiglow LED T8 Lamps Due to Injury Hazard

10-06-2020

The recalled lamps can overheat causing the glass tube to fall and strike those standing nearby, posing an injury hazard.  

Product safety

Island Wear Recalls Strollers Due to Violation of Federal Stroller and Carriage Safety Standard; Fall and Choking Hazards

10-06-2020

The recalled strollers violate the federal Carriages and Strollers Safety standard. The location of the restraint system creates a large gap between...

Product safety

DICK’S Sporting Goods Recalls Safety Ropes Due to Fall and Injury Hazards

10-06-2020

The ropes can fail when used in freezing conditions, posing fall and injury hazards 

News

Chinese Manufacturer Charged with Exporting Misbranded and Defective Masks Falsely Purporting to be N95 Respirators

08-06-2020

Chinese, manufacturer, charged, exporting, misbranded, defective masks, N95 respirators, false, mislabeled, first responders, healthcare workers,...

News

Animal Health International Sentenced on Federal Misbranding Charge

08-06-2020

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

08-06-2020

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