America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) issued seven new safety alerts in the final two weeks of September, six related to product recalls and one safety communication related to cybersecurity.

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 1, 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.

Cybersecurity Vulnerabilities Tied to Using Certain Medical Devices
> Issue date: October 1, 2019
> Type of notice: Safety communication

Security researchers have identified 11 cybersecurity vulnerabilities called Urgent/11 that could allow anyone to take control of certain medical devices from a remote location. Once control is established, the device’s function may be changed, a denial of service could occur or information or logical flaws could be introduced to prevent the device from functioning.

Skin Prep Lotion That Enhances Electrode Signal Quality Recalled
> Issue date: September 26, 2019
> Type of notice: Recall

Mavidon is voluntarily recalling 21 lots of LemonPrep 4-ounce tubes and single-use cups that may be contaminated with Burkholderia cepacia, a multi-drug-resistant pathogen that could cause serious infections and may be life-threatening for patients with compromised immune systems.

Impurity Found in Anti-Acid Medicine
> Issue date: September 25, 2019
> Type of notice: Recall

Apotex is voluntarily recalling its ranitidine Tablets (75 mg and 150 mg in all pack sizes and formats). The FDA and other global regulators have found that some ranitidine anti-acid medicines may contain an impurity that has been classified as a possible human carcinogen.

Potential Leakage in Infusion Pump
> Issue date: August 28, 2019 (added to Medwatch in late September)
> Type of notice: Recall

B. Braun Medical is voluntarily recalling one lot of its Infusomat Space Volumetric Infusion Pump Administration Set that may leak and/or disconnect at the bonded joint between the tubing and injection site. A total of 2,580 units manufactured in September 2018 were distributed between November 23, 2018 and March 20, 2019.

Impurity Found in Anti-Acid Medicine
> Issue date: September 23, 2019
> Type of notice: Recall

Sandoz is voluntarily all quantities and lots of ranitidine hydrochloride capsules in the United States. The FDA and other global regulators have found that some ranitidine anti-acid medicines may contain an impurity that has been classified as a possible human carcinogen.

Expanded Recall of Hypertension Medicine
> Issue date: September 19, 2019
> Type of notice: Recall

Torrent Pharmaceuticals is expanding its recall of losartan potassium/hydrochlorothiazide tablets due to the detection of trace amounts of an unexpected impurity.

Dietary Supplement Recalled
> Issue date: September 16, 2019
> Type of notice: Recall

Fitoterapia USA is voluntarily recalling 19,000 bottles of its Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement. The FDA found the product to be tainted with tadalafil, an FDA-approved prescription drug used to treat male erectile dysfunction. The presence of tadalafil in Macho is unapproved for safety and efficacy and is subject to recall.