Drug product
Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01
D-1243-2019
Product summary
- Firm
- LUPIN SOMERSET
- Event
- Event 82581
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,328 bottles
- Official record key
drug-enforcement:D-1243-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot#: S700220, Exp. Apr 30 2019; S700604, Exp. July 31 2019; S800326, Exp. Mar 31 2020
Distribution pattern: Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications