FDA Recall D-1187-2022
Bryant Ranch Prepack, Inc. · Burbank, CA
Class I — life-threatening Terminated 655 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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.
Recall record
- Recall number
D-1187-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed to one wholesaler in AL for further distribution in the US.
- Recall initiated
- 2022-06-17
- Classified by FDA Center
- 2022-07-08
- FDA published
- 2022-07-20
- Terminated
- 2024-04-02
- Recalling firm
- Bryant Ranch Prepack, Inc.
- Firm location
- Burbank, CA