America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) issued seven new safety alerts in the past week, one safety communication and six product recalls, four of which are related to ranitidine, the generic version of Xantac.

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 November 19, 2019. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The most serious alert is a Class I recall, indicating that continued use of these devices may cause serious injury or death. 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.

Ranitidine Antacid Medication Recalled
> Issue date: November 19, 2019
> Type of alert: Recall

Precision Dose voluntarily recalling five lots of Ranitidine Oral Solution, USP 150 mg/10 mL that may be contaminated with excess levels of a carcinogen known as NDMA.

Device Failure Associated With Aortic Balloon Pumps
> Issue date: November 19, 2019
> Type of alert: Letter to health care providers

The FDA had issued a follow-up notice to health care providers regarding the failure of Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. More than 60 additional reported failures have occurred since the original November 1 warning, and two patients have died and another suffered serious injury.

Ranitidine Antacid Medication Recalled
> Issue date: November 15, 2019
> Type of alert: Recall

Golden State Medical Supply is voluntarily instituting a recall of all quantities and lots of Ranitidine HCl 150 mg and 300 mg capsules because of the potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA.

Male Enhancement Drug May Contain an Undeclared Ingredient
> Issue date: November 13, 2019
> Type of alert: Recall

Nature’s Rx is voluntarily recalling one lot of Silver Bullet (10 male enhancement capsules) that FDA inspectors found to contain undeclared sildenafil (Viagra). The drug may pose serious health risks to consumers with underlying medical issues like diabetes, high blood pressure or heart disease.

Ranitidine Antacid Medication Recalled
> Issue date: November 12, 2019
> Type of alert: Recall

Amneal Pharmaceuticals is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg and Ranitidine Syrup (Ranitidine oral solution, USP), 15 mg/mL because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Dietary Supplement May Be Tainted With Undeclared Ingredient
> Issue date: November 8, 2019
> Type of alert: Recall

Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement may be tainted with undeclared sildenafil (Viagra).