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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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Product safety

Humanscale Recalls QuickStand Lite Workstations Due to Injury Hazard

17-09-2019

The recalled workstation’s arm can break and cause the workstation to fall, posing a risk of injury.

Food & drugs

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...

Food & drugs

Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lun

13-09-2019

FDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers...

Food & drugs

Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines

12-09-2019

FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA.

Food & drugs

Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer

12-09-2019

Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer

Food & drugs

Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error

12-09-2019

Darmerica LLC is voluntarily recalling two lots, DR4654A and DL4654A, of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles...

Food & drugs

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of

12-09-2019

KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. ...

Food & drugs

The Metrix Company of Dubuque, Iowa is Recalling Specific Lots of the Empty IV Flexible Containers (Bag) Marketed Under the Met

10-09-2019

The Metrix Company of Dubuque, Iowa is recalling specific lots of the empty IV flexible containers (bag) marketed under the Metrix Secure EVA Dual...

Product safety

Healing Solutions Recalls Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning

10-09-2019

The bottles are not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if the contents are swallowed by...

Product safety

Air Rifles Recalled by DIANA Can Unexpectedly Discharge; Risk of Serious Injury and Death

10-09-2019

The air rifle can unexpectedly discharge even if the safety is engaged. This can result in a serious injury or death.

Product safety

Ragdoll & Rockets Recalls Children’s Loungewear Due to Violation of Federal Flammability Standard

10-09-2019

The children’s loungewear fails to meet the flammability standards for children’s sleepwear, posing a risk of burn injuries to children.

Food & drugs

Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication

09-09-2019

Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential...