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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

Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by H

05-09-2017

If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as...

Food & drugs

Country Fresh Orlando LLC, Recalls Product Because of Possible Health Risk

05-09-2017

Country Fresh Orlando, LLC. of Orlando, Florida, is recalling 5,999 cases of diced bell pepper, vegetable kabobs, and creole and fajita mixed diced...

Product safety

ASHERANGEL Recalls Children’s Sleepwear Due to Violation of Federal Flammability Standard; Sold Exclusively at Amazon.com (Reca

05-09-2017

The children’s nightgowns and pajama sets fail to meet flammability standards for children’s sleepwear, posing a risk of burn injuries to...

Product safety

American Honda Recalls Motocross Off-Road Motorcycles Due to Crash and Injury Hazards (Recall Alert)

05-09-2017

The transmission gear can break, posing crash and injury hazards.

Food & drugs

Wakefern Food Corp. Voluntarily Recalls ShopRite Semi-Sweet Real Chocolate Chips

02-09-2017

Wakefern Food Corp. has initiated a voluntary recall of its ShopRite brand Semi-Sweet Real Chocolate Chips. The chips were sold in 24 oz. bags...

Food & drugs

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated R

01-09-2017

PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots...

Food & drugs

Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection, USP, CII, (2 mg/mL) 1mg/mL Vial, and Levophe

01-09-2017

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of...

Food & drugs

Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility

01-09-2017

The use of these alcohol pads and antiseptic towelettes could cause infections.

Food & drugs

Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Su

01-09-2017

An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and...

Food & drugs

Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold

31-08-2017

Risks associated with the use of Keytruda in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the...

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Europe Travel Alert

31-08-2017

Food & drugs

Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter

31-08-2017

If administered to a patient, particulate may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma.