Drug product
Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01
D-0249-2025
Product summary
- Event
- Event 96242
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9840 bottles
- Official record key
drug-enforcement:D-0249-2025
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: AD16615, Exp. Date 07/2025
Distribution pattern: Nationwide within in the USA.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications