Drug product
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
D-0358-2022
Product summary
- Event
- Event 89324
- Status
- Terminated
- Classification
- Class III
- Quantity
- 23,965 100 count bottles
- Official record key
drug-enforcement:D-0358-2022
Official wording
Reason: Out-of-specification impurity test result observed at 18-month long term stability time point.
Code information: Lot # S000268, Exp. date January 2022
Distribution pattern: Product Distributed in NY and OH.
Derived failure modes
-
Potency or specification failure
Out-of-specification