Glass Particles Force Reglan Recall

By October 11, 2013 July 16th, 2019 Reglan

Hospira, the manufacturers of a generic version of the acid reflux drug Reglan, has issued a recall of the pills after it was discovered that the drug contained strands of glass. The recall was announced by the FDA on October 1.

While no adverse events reports have come in about the contaminated Reglan at the time of this writing, it is a concern that the glass could be dislodged from the vials and accidentally be injected into the patients taking the drugs. Should that happen, it could cause the patient to experience inflammation, allergic reactions and thrombophlebitis.

According to an article about the recall on AboutLawsuits.com, the recall “affects one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK. They were packaged in 2 mL single-dose fliptop vials, with an expiration date of October 1, 2014. It also affects two lots of Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK. They were packaged in 2 mL, single-dose fliptop vials, with an expiration date of May 1, 2015.”

Reglan is used to treat acid reflux and GERD, and is only to be used for periods lasting no longer than 12 weeks. When used longer, the drug can cause patients to suffer from serious adverse side effects including tardive dyskinesia. Tardive dyskinesia is a condition that causes patients to experience Parkinson’s-like symptoms, including involuntary movement of the extremities, excessive and uncontrollable blinking, tongue protrusion, grimacing and more.

The side effects linked to Reglan use have caused thousands of former users to file lawsuits against the makers of the drug, alleging failure to warn. A Reglan lawsuit (Mensing vs. Pliva)was also the focus of The Supreme Court’s ruling to disallow generic drug makers to be sued over side effects. The ruling was recently reviewed and upheld due to the fact that state laws only require that generic drug makers duplicate the warnings listed on their generic counterparts.