Safety Alerts and Recalls

Safety Alerts & Recalls

Cancer Tx Recalled Due to Visible Particulate Matter

The Food and Drug Administration (FDA) announced that Teva Parenteral Medicines is voluntarily recalling eight lots of Adrucil (fluorouracil injection) due to the potential presence of visible foreign particulate matter.

Flu Vaccine Recalled Due to Sub-Potency

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) announced that Sanofi Pasteur is voluntarily recalling three lots of its Fluzone Quadrivalent (quadrivalent inactivated "split virus" influenza vaccine [Types A and B]) due to potency issues.

FDA: Beware of Hidden Ingredients in Multiple Supplements

The Food and Drug Administration (FDA) is warning consumers not to use or buy the following tainted supplements marketed for weight loss and sexual enhancement:

Healthcare Antiseptics Under Scrutiny by FDA Over Safety, Efficacy

The Food and Drug Administration (FDA) has issued a proposed rule requesting additional scientific data to support the safety and efficacy of certain ingredients in antiseptics used in healthcare and marketed under the over-the-counter drug monograph.

14 Warning Letters Issued Over DMBA Presence in Supplements

The Food and Drug Administration (FDA) has issued warning letters to fourteen manufacturers of dietary supplements due to the listing of 1,3-Dimethylbutylamine (also known as DMBA, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine) on the product label.

Numerous Injectable Products Recalled Due to Foreign Matter

Mylan announced a voluntary recall of multiple injectable products due to the potential presence of visible foreign particulate matter.

FDA, Manufacturers Battling Over BMPEA

The Food and Drug Administration (FDA) has issued warning letters to five manufacturers of dietary supplements due to the listing of R-beta-methylphenethylamine (also known as Beta-methylphenethylamine, βMePEA, or BMPEA) on the product label.

Recall Issued for Ebola Virus One-Step Test Kits

The Food and Drug Administration (FDA) has issued a Class 1 recall for the Ebola Virus One-Step Test Kits (LuSys Laboratories). This test kit has not been cleared or approved by the FDA for in vitro diagnostic detection of Ebola Virus infection.

Norpace CR Still in Shortage, Anticipated Availability Announced

The Food and Drug Administration (FDA) announced that Norpace CR (disopyramide phosphate; Pfizer) controlled-release 100mg is currently in shortage.

FDA: Hypertension Tx Currently in Shortage

The Food and Drug Administration (FDA) announced that Bystolic (nebivolol; Forest Laboratories) 20mg is currently in shortage.