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FDA Safety Alerts for Tuesday, May 7, 2019

May 7, 2019

These Food and Drug Administration (FDA) safety alerts were recently posted:

 

Recall of Mycophenolate Mofetil

Par Pharmaceuticals Inc. is recalling mycophenolate mofetil injection USP due to the presence of glass. The voluntary recall is limited to 1 lot of mycophenolate that was distributed in the U.S. between January 23, 2019 and February 11, 2019. Use of this product could potentially result in local irritation or swelling as well as more serious outcomes such as blockage and clotting in blood vessels. More Information.

 

FDA Update on the Safety of Breast Implants

The FDA Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel convened in March 2019 to discuss breast implant safety, particularly the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Based on current evidence, the FDA will continue to allow the marketing of textured breast implants. The FDA is implementing steps to ensure transparency of breast implant adverse events and to improve the availability of information to healthcare providers and patients regarding the risks associated with breast implants. More Information