Drug product
Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01.
D-1187-2022
Product summary
- Event
- Event 90481
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1187-2022
Official wording
Reason: 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.
Code information: Lot #: 179642, Exp. Date 11/30/2023.
Distribution pattern: Distributed to one wholesaler in AL for further distribution in the US.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up