FDA Reports Recall of Morphine Sulfate Extended-Release Tablets Because of Label Mix-Up
On June 28, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-inc-issues-voluntary-nationwide-recall-morphine-sulfate-30-mg-extended-release?utm_medium=email&utm_source=govdelivery) Bryant Ranch Prepack Inc.’s voluntarily recall of one lot of morphine sulfate 30 mg extended-release tablets and one lot of morphine sulfate 60 mg extended-release tablets because the products are incorrectly labeled. Bottles labeled as 60 mg tablets may contain 30 mg tablets and bottles labeled as 30 mg may have 60 mg tablets.
Patients prescribed a 30 mg dose who receive 60 mg could be at risk for overdose and death. Patients prescribed a 60 mg dose who receive 30 mg may experience withdrawal and untreated pain. To date, Bryant Ranch Prepack Inc. has not reported any adverse events related to the recall.
The following products are included in the recall:
|Product||Strength||Quantity Per Bottle||NDC||Lot||Expiration|
|Morphine sulfate extended-release tablets||30 mg||100||63629-1088-01||179642||11/30/2023|
FDA reported that Bryant Ranch Prepack Inc. is notifying distributors and consumers by email, phone, and letter. They are also arranging for return of all recalled products. Consumers and healthcare providers who have the recalled product should stop use.
Consumers with questions regarding this recall can contact Bryant Ranch Prepack Inc. at 877-885-0882 or firstname.lastname@example.org (mailto:email@example.com) Monday–Friday, from 7:30 am–5 pm PDT. Patients should contact their healthcare provider if they experience any problems that may be related to taking this product.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.