Safety Report: Bryant Ranch Prepack Inc Morphine Sulfate 30mg - recalled due to Incorrect labeling, USA

United States

Bryant Ranch Prepack Inc. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (Comprised of 10 bottles), and one lot of Morphine Sulfate 60 mg Extended-Release tablets (Comprised of 10 bottles) to the consumer level listed below. The products have been found to have incorrect labeling where bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. 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. To date, Bryant Ranch Prepack Inc. has not received any reports of adverse events related to this recall.

-Affected products:
Product: Morphine Sulfate Extended-Release Tablets
Strength: 30 mg
Quantity per bottle: 100
NDC: 63629-1088-01
Lot: 179642
Expiration: 11/30/2023

Product: Morphine Sulfate Extended-Release Tablets
Strength: 60 mg
Quantity per bottle: 100
NDC: 63629-1089-01
Lot: 179643
Expiration: 08/31/2023

Morphine Sulfate Extended-Release tablets are used to manage severe pain. The 30 mg tablets are round, purple-colored, film-coated tablets debossed with "RD" and "71" on one side and plain on the other side. The 60 mg tablets are round, light orange-colored, film-coated tablets debossed with "RD" and "72" on one side and plain on the other side.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Bryant Ranch Prepack Inc.
Brand name: Bryant Ranch Prepack Inc.
Product recalled: Morphine Sulfate 30 mg Extended-Release tablets
Reason of the recall: Incorrect labeling
FDA Recall date: June 29, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-inc-issues-voluntary-nationwide-recall-morphine-sulfate-30-mg-extended-release