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Morphine Sulfate Extended-Release Tablets Recalled Due To Label-Mix Up

bryantranch jun30 lt

Bryant Ranch Prepack Inc. is recalling certain Morphine Sulfate Extended-Release Tablets citing incorrect labeling, the U.S. Food and Drug Administration said.

The recall involves one lot of Morphine Sulfate 30 mg Extended-Release tablets, and one lot of Morphine Sulfate 60 mg Extended-Release tablets to the consumer level. Both are comprised of 10 bottles each, and quantity per bottle is 100 tablets.

The 30 mg Morphine tablets come with NDC 63629-1088-01, lot 179642 and expiration date of 11/30/2023, while 60 mg Morphine tablets come with NDC 63629-1089-01, lot 179643 and expiration date of 08/31/2023.

The 30 mg tablets are round, purple-colored, film-coated tablets, and 60 mg tablets are round, light orange-colored, film-coated tablets.

According to the agency, 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.

Morphine Sulfate Extended-Release tablets are used to manage severe pain.

Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death, while 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.

Burbank, California -based Bryant Ranch has not received any reports of adverse events related to the recall to date.

Consumers/distributors/retailers that have the recalled products are urged to stop using it and to contact the company.

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