Bryant Ranch Prepack Inc. has voluntarily recalled 1 lot of Morphine Sulfate 30mg Extended-Release tablets and 1 lot of Morphine Sulfate 60mg Extended-Release tablets due to incorrect labeling resulting in bottles labeled with the 60mg dose containing 30mg tablets and vice versa.
Morphine Sulfate Extended-Release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The recalled lots include Morphine Sulfate 30mg Extended-Release tablets; NDC 63629-1088-01; Lot #17642; Expiration Date 11/30/2023, and Morphine Sulfate 60mg Extended-Release tablets; NDC 63629-1089-01; Lot #17643; Expiration Date 8/31/2023.
According to the Company, patients prescribed the 30mg dose who receive the 60mg dose may potentially be at risk for overdose and death. Patients prescribed the 60mg dose who receive the 30mg dose may experience withdrawal and untreated pain. To date, the Company has not received any adverse event reports related to the recall.
Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Bryant Ranch Prepack Inc. issues voluntary nationwide recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release due to label-mix up. News release. Bryant Ranch Prepack Inc. June 29, 2022. Accessed July 5, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-inc-issues-voluntary-nationwide-recall-morphine-sulfate-30-mg-extended-release