Bryant Ranch Prepack, Inc. recalls Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories In…

Recall date

June 17, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1188-2022

FDA classification

Class I

Brand / firm

Bryant Ranch Prepack, Inc.

Sold / distributed

Distributed to one wholesaler in AL for further distribution in the US.

Why it was recalled

Labeling: Label Mix-up: 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01