D-1187-2022 Class I Terminated
FDA drug recall D-1187-2022 was initiated by Bryant Ranch Prepack, Inc. on June 17, 2022 and is designated Class I. Reason for recall: 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 Extend… The recall status is terminated (terminated April 2, 2024).
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2022
- Initiation Date
- June 17, 2022
- Termination Date
- April 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Distributed to one wholesaler in AL for further distribution in the US.
Code Information
Lot #: 179642, Exp. Date 11/30/2023.