Drug product
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01
D-1214-2018
Product summary
- Firm
- LUPIN SOMERSET
- Event
- Event 80874
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4716 bottle
- Official record key
drug-enforcement:D-1214-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Code information: Lot# S800232, Exp 2/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
out of Specification