D-1188-2022 Class I Terminated
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; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
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 #: 179643, Exp. Date 08/31/2023.