D-0358-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 12, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- August 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,965 100 count bottles
Product Description
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.
Distribution Pattern
Product Distributed in NY and OH.
Code Information
Lot # S000268, Exp. date January 2022