America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) issued seven new safety alerts between October 16 and 23, one product notification and six product recalls.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all Medwatch alerts for 2019 through October 23, 2019. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are listed in reverse chronological order with the most recent listed first. Included are the type of alert and the issue date.

Heartburn Reliever Recalled
> Issue date: October 23, 2019
> Type of alert: Recall

Perrigo is voluntarily recalling all its ranitidine over-the-counter products sold in the United States. The products may be contaminated with a carcinogen known as NDMA.

Heartburn Reliever Recalled
> Issue date: October 23, 2019
> Type of alert: Recall

Dr. Reddy’s Laboratories is voluntarily recalling all Dr. Reddy’s ranitidine over-the-counter products sold in the United States. The products may be contaminated with a carcinogen known as NDMA.

Heartburn Reliever Recalled
> Issue date: October 23, 2019
> Type of alert: Recall

Sanofi is voluntarily recalling all Zantac (ranitidine) over-the-counter tablets sold in the United States. The products may be contaminated with a carcinogen known as NDMA.

Dietary Supplement for Male Sexual Enhancement Recalled
> Issue date: October 22, 2019
> Type of alert: Recall

GL Holdings is voluntarily recalling six lots of its Green Lumber 2-, 4- and 10-capsule packets that may be tainted with tadalafil, a prescription-only product that may be a risk to consumers who also take medications containing nitrates.

Baby Powder Recalled
> Issue date: October 18, 2019
> Type of alert: Recall

Johnson & Johnson voluntarily recalled a single lot of its Johnson’s Baby Powder in response to an FDA Test indicating that sub-trace levels of chrysotile asbestos (no more than 0.00002%) were found in a single bottle purchased from an online retailer.

Improperly Printed Product Information
> Issue date: October 16, 2019
> Type of alert: Product information

CSL Behring alerted customers to misprinted information on its folding box of Humate-P. The expiration date may not be printed in the proper location. See the MedWatch alert for photos of the incorrect and correct labeling.