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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

Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spec

28-10-2020

Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning...

Food & drugs

Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microb

28-10-2020

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from...

Food & drugs

Allergy Alert Issued for Undeclared Egg in Prepared Macaroni & Cheese Sold at Whole Foods Market Stores in Five States

28-10-2020

Whole Foods Market is voluntarily recalling select prepared Macaroni & Cheese products from stores across five states because they contain...

Food & drugs

Homestead Creamery Issues Voluntary Glass Bottled Product Recall

28-10-2020

Homestead Creamery of Wirtz, VA is voluntarily recalling glass bottled products because of a suspected issue with the bottle sanitizing process....

Food & drugs

Russ Davis Wholesale Issues Allergy Alert on Undeclared Egg in Mixed Veggie Cup With Dip

28-10-2020

Russ Davis Wholesale of Wadena, Minnesota is recalling individual serving cups of Mixed Veggie Cup with Dip because it may contain undeclared Egg....

Product safety

Porter World Trade Recalls Ron Jon Surf Shop Sippy Cup Due to Violations of Federal Lead Content and Phthalates Bans

28-10-2020

The plastic characters on the recalled Sippy Cup contain levels of lead that exceed the federal lead content ban and contain levels of a regulated...

Product safety

Schneider Electric Recalls Surgeloc™ Surge Protection Devices Due to Fire Hazard

28-10-2020

The Surgeloc Surge Protection Device can experience an arc event, which can result in a fire hazard.

News

Three Men Plead Guilty to Healthcare Kickback Conspiracies

27-10-2020

FDA OCI, Daniel Walker, Lewes DE, Michael Beatty, Pasadena MD, Seth Myers, Crystal Lake IL, guilty plea, health care kickbacks, conspiracy,...

News

Suboxone Manufacturer Indivior's Former Chief Executive Officer Sentenced to Jail Time in Connection with Drug Safety Claims

27-10-2020

FDA OCI, Suboxone, CEO, Indivior, CEO, sentence, jail, drug safety claims, Shaun Thaxter, 6 months jail, misbranded drug, Suboxone Film, Reckitt...

Food & drugs

Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microb

27-10-2020

Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from...

News

Forest Park Anesthesiologist Sentenced to 5.5 Years in Federal Prison

26-10-2020

FDA OCI, Richard Toussaint, M.D., Forest Park Medical Center, $82.9 million, , sentence, anesthesiologist, fraud, restitution, Dr. Wade Barker,...

Food & drugs

Allergy Alert Issued By Incredible Fish, Inc. for Undeclared Milk, Fish and Eggs in Incredible Stone Crab Mustard Sauce

24-10-2020

Incredible Fish, Inc. is voluntarily recalling a small quantity of Incredible Stone Crab Mustard Sauce because its labeling inadvertently did not...