‘Label Mix-Up’ Could Pose Overdose Or Withdrawal Risk

A company is voluntarily recalling certain morphine sulfate products because of a “label mix-up.” The products may pose overdose or withdrawal risks if consumers take a higher or lower dose than prescribed.

The recall affects one lot each of Bryant Ranch Prepack’s Morphine Sulfate 30 mg Extended-Release tablets and Morphine Sulfate 60 mg Extended-Release tablets, according to the company announcement posted on the U.S. Food and Drug Administration (FDA) website.

The problem is that the affected products have “incorrect” labels, wherein the bottles labeled to have the 60-milligram tablets may actually contain 30-milligram tablets, while the bottles labeled to have 30-milligram tablets may instead contain the 60-milligram tablets.

Morphine sulfate is a type of opiate and analgesic agent. The recalled product is intended for the management of severe pain, the company noted.

Because of the mix-up, patients who have the product may be in possession of tablets that have either a lower or a higher dose than they were prescribed. Those who were prescribed with 30-milligram dosage but got 60-milligram tablets may be at risk of overdose or even death, the company said. On the other hand, those who were prescribed with 60-milligram dosage but got 30-milligram tablets may experience “withdrawal and untreated pain.”

“To date, Bryant Ranch Prepack Inc. has not received any reports of adverse events related to this recall,” the company noted. “Bryant Ranch Prepack is notifying its distributors and customers by email, phone and letter, and is arranging for return of all recalled products.”

The affected 30-milligram tablets are purple colored and had the NDC 63629-1088-01, Lot Number 179642 and expiration date of 11/30/2023. The recalled 60-milligram products, on the other hand, were light orange in color and had NDC 63629-1089-01, Lot Number 179643 and expiration date of 08/31/2023. Photos of the tablets and the packaging are available on the FDA website.

Those who are in possession of an affected product are being advised to not use it. Instead, they may contact the company at 877-885-0882 or cs@brppharma.com.

“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” the company advised.

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