Drug product
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01
D-1245-2019
Product summary
- Firm
- LUPIN SOMERSET
- Event
- Event 82581
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,284 bottles
- Official record key
drug-enforcement:D-1245-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 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