Mislabeled Morphine Garners Class I Recall

Bryant Ranch Prepack Inc is recalling a single lot of morphine sulfate 30-mg extended-release tablets and a single lot of morphine sulfate 60-mg extended-release because of a labeling mix-up. According to the July 20, 2022, US Food and Drug Administration (FDA) Enforcement Report, bottles labeled for 60-mg tablets contain 30-mg tablets, while bottles labeled for 30-mg tablets may contain 60-mg tablets.

The FDA has designated the recall Class I, which warns use of the affected tablets could cause serious adverse health consequences or death.

“Patients prescribed the 30-mg dose who receive the 60-mg dose could be at risk for overdose and death,” Bryant Ranch Prepack stated in a June 28, 2022, company announcement. “Patients prescribed the 60-mg dose who receive the 30-mg dose may experience withdrawal and untreated pain if the dose given is too low.”

The recall affects the following products, which were manufactured by Ohm Laboratories Inc, New Brunswick, NJ, and relabeled by Bryant Ranch Prepack, Burbank, CA:

• morphine sulfate extended-release tablets, 30 mg, 100-count bottles (NDC 63629-1088-01), from lot 179642 (Exp. 11/30/23); and
• morphine sulfate extended-release tablets, 60 mg, 100-count bottles (NDC 63629-1089-01), from lot 179643 (Exp. 8/31/23).

The tablets were sent to a wholesaler in Alabama for distribution throughout the United States.

Bryant Ranch Prepack voluntarily initiated the recall June 17, 2022. On July 8, 2022, the FDA issued its Class I designation. As of June 28, 2022, Bryant Ranch Prepack had not received any reports of adverse events related to the recall.

Morphine sulfate extended-release tablets are available with a prescription for the management of severe pain.