America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has issued four new safety alerts, all related to product recalls, including a recall of a fentanyl (opioid) transdermal patch.

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 April 24. 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, so the most recent are listed first. Included are the type of alert and the issue date.

Legacy Pharmaceutical Packaging Recall
> Issue date: April 24, 2019
> Type of alert: Recall

Legacy Pharmaceutical Packaging is expanding its recall of three lots of 50 mg Losartan tablets to include a fourth lot related to a recall of the tablets by Torrent Pharmaceuticals due to the detection of a contaminant in the tablets.

Alvogen Recalls Fentanyl Transdermal Patch System
> Issue date: April 19, 2019
> Type of alert: Recall

Alvogen is voluntarily recalling two lots (180060 and 180073) of its 12 mcg/h fentanyl transdermal patch system with an expiration date of May and June 2020. Some of the cartons contain 50 mcg/h doses. According to the FDA, using the higher dosage patch “could result in serious, life threatening, or fatal respiratory depression.”

Torrent Pharmaceuticals Recalls More Losartan Tablets
> Issue date: April 18, 2019
> Type of alert: Recall

Torrent Pharmaceuticals has expanded its recall of 50 mg Losartan tablets to include 36 lots of Losartan potassium tablets and 68 lots of Losartan potassium/hydrochlorothiazide tablets due to possible contamination.

Brainlab Recalls Surgical Navigation Software
> Issue date: April 15, 2019
> Type of Alert: Recall

Brainlab is recalling its Brainlab Spine & Trauma 3D Navigation software used in its systems to help surgeons safely navigate surgical tools and implants used before and during minimally invasive surgical procedures. The recall covers 60 systems sold in the United States. The FDA classifies this as a Class I recall, which means that using the devices may cause serious injury or death.