America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) issued nine new safety alerts in the first two weeks of September, six related to product recalls, two safety communications, and one consumer-focused information release related to vaping.

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 September 13, 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.

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.

Impurity Found in Some Anti-Acid Medicine
> Issue date: September 12, 2019
> Type of alert: Safety information

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.

Label Mix-Up Leads to Recall of Compounding Drug
> Issue date: September 12, 2019
> Type of alert: Recall

Darmerica is voluntarily recalling two lots of mislabeled quinacrine dihydrochloride. Due to a label mix-up, bottles labeled as containing quinacrine contain artemisinin.

Human and Animal Drugs Recalled Due to Lack of Assurance of Sterility
> Issue date: September 12, 2019
> Type of alert: Recall

KRS Global Biotechnology is recalling all lots of human and animal drugs distributed nationwide that may not be sterile. The products and lot numbers are listed at the FDA’s website.

IV Bags May Leak and Cause Serious Infection
> Issue date: September 10, 2019
> Type of alert: Recall

The Metrix Company of Dubuque, Iowa, is recalling specific lots of empty IV bags sold under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix brands. The bags could leak, resulting in a serious infection to the patient.

Milk of Magnesia Products Recalled
> Issue date: September 9, 2019
> Type of alert: Recall

Plastikon Healthcare is voluntarily recalling two lots of its milk of magnesia 2400 mg/30 mL oral suspension because the products did not meet the company’s own specification for total aerobic microbial count. The product is packaged and sold to institutions.

Bacteriostatic Water May Not Be Sterile
> Issue date: September 6, 2019
> Type of alert: Recall

Hospira, a division of Pfizer, is recalling one lot of its bacteriostatic water for injection due to lack of confirmation of sterility. The product is to be used only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection.