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 for recall: Out-of-specification impurity test result observed at 18-month long term stability time point.
Recall initiated: 20211229
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated