Drug product
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
D-0037-2025
Product summary
- Event
- Event 95588
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 532 100-count bottles
- Official record key
drug-enforcement:D-0037-2025
Official wording
Reason: Failed Impurities/Degradation Specification
Code information: Lot# FG13996, Exp 09/30/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specification