Class I Recall for Mislabeled Muscle Relaxant

A labeling error listing an incorrect tablet strength has prompted Bryant Ranch Prepack Inc to recall a single lot of methocarbamol tablets. According to the November 10, 2021, US Food and Drug Administration (FDA) Enforcement Report, the FDA issued its most serious designation for the recall, Class I, which warns use of the affected product could cause serious adverse health consequences or death.

Product bottles are labeled to contain methocarbamol 500 mg tablets but actually contain 750 mg tablets, the report explained. Methocarbamol is a prescription muscle relaxant used in the treatment of acute musculoskeletal pain and conditions.

“If a patient takes a 750 mg tablet of methocarbamol instead of the prescribed 500 mg tablets, it potentially could result in excessive central nervous system depression, which may result in nausea, sedation, fainting, falls, seizure, coma, and death,” recaller Bryant Ranch Prepack stated in an October 18, 2021, announcement. “Bryant Ranch Prepack has not received any reports of adverse events related to this recall.”

The recall affects methocarbamol 500-mg tablets in 30-count (NDC 7133517952), 60-count (NDC 7133517954), and 90-count (NDC 7133517957) bottles from lot 163935 (Exp: 10/31/22). The tablets were packaged by Bryant Ranch Prepack, Burbank, CA, and distributed to physician offices throughout the United States.

“Consumers that have the bottles labeled as methocarbamol 500 mg tablets, which is being recalled, should stop using immediately and return to place of purchase and/or contact their physician,” the company advised. “Distributors/physicians should stop distribution and contact Bryant Ranch Prepack to return the product immediately.”

Bryant Ranch Prepack voluntarily initiated the recall October 12, 2021. The FDA classified the recall Class 1 on November 2, 2021.