Recall: D-0358-2022

Class III - Minor Violations

Class IIIClassification

2021-12-29Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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.

Distribution

Product Distributed in NY and OH.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.