MedicineWatch US
Class III Recall

Lupin Pharmaceuticals Inc.

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
Reason
Out-of-specification impurity test result observed at 18-month long term stability time point.
Classification
Class III
Status
Terminated
Lot
Lot # S000268, Exp. date January 2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Lupin Pharmaceuticals Inc. — Class III Recall | MedicineWatch US