America’s Unsafe Drugs and Medical Products

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

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Impurity Found in Anti-Acid Medicine
> Issue date: September 25, 2019
> Type of alert: Recall and safety information

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.

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.

Some ranitidine medicines, including Zantac, may contain an impurity that has been classified as a possible human carcinogen. The FDA recommends that patients taking prescription ranitidine talk to their doctors about an alternative and further recommends that over-the-counter users should consider other similarly available medicines.

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

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

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

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Severe Lung Inflammation in Some Patients Being Treated for Breast Cancer
> Issue date: September 13, 2019
> Type of alert: Safety communication

Some breast cancer patients being treated with Ibrance (palbociclib), Kisqali (ribociclib) and Verzenio (abemaciclib) have experienced severe lung inflammation. The FDA has approved new warnings of this risk and noted that the overall benefit of the drugs remains greater than the risks when used as prescribed.