Recent Drug Recalls

Kratom Powder from PDX Aromatics

Kratom is a plant and sold as a stimulant dietary supplement for the treatment of opioid withdrawal symptoms. PDX Aromatics issued a recall for their Kratom powder because of potential Salmonella contamination. Since October of 2017, 87 people across the United States have contracted Salmonella connected to the powder.

Limbrel from Primus Pharmaceuticals Inc.

Limbrel is an oral osteoarthritis drug that the FDA issued a warning for in January of 2018. The FDA issued a recall due to adverse reports of elevated liver function tests and acute hypersensitivity pneumonitis (inflammation of the alveoli within the lung) in patients who had taken the drug. Currently, the drug has not caused any deaths, but serious symptoms often require hospitalization. Since Limbrel is categorized as a medical food product, it was not evaluated for safety by the FDA before being marketed.

Zinbryta from Biogen, AbbVie

Biogen and AbbVie, makers of the MS drug, Zinbryta, have issued a voluntary withdrawal of the drug globally. Recently, the drug was flagged with a lethal safety warning for inflammatory encephalitis and meningoencephalitis that can be caused by viruses and result in inflammation of the brain and surrounding tissues (Carroll, 2018). In 2016, Zinbryta was flagged with a black box warning by the FDA for liver toxicity.

Various Injectable Drugs from Cantrell Drug

On March 1, 2018 the FDA issued a warning to health care professionals and patients not to use “opioid products and other drugs intended for sterile injection” (FDA, 2018). The FDA sites “serious deficiencies” in Cantrell’s processes to ensure the quality and sterility of the drugs. They specifically called out Cantrell’s “poor compounding drug operations,” “unsanitary conditions and violations of current Good Manufacturing Practice” that could cause the products to become contaminated. Despite warnings from the FDA to stop producing and distributing drugs, Cantrell continued with business as usual.

Sources

Biogen. (2018, March 2). Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis. Retrieved March 16, 2018, from https://media.biogen.com/press-release/autoimmune-diseases/biogen and-abbvie-announce -voluntary worldwide-withdrawal-marketing/

Carroll, J. (2018, March 02). Biogen, AbbVie yank MS drug Zinbryta off the market in the wake of encephalitis cases. Retrieved March 15, 2018, from https://endpts.com/biogen-abbvie-yank-ms-drug-zinbryta-off-the-market-in-the-wake-of-encephalitis-cases/

FDA. (2018, January 26). Recalls, Market Withdrawals, & Safety Alerts – Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA’s Cooperation to Restore Access for Patients with Medical Necessity. Retrieved March 16, 2018, from https://www.fda.gov/Safety/Recalls/ucm594357.htm