Class III
Terminated
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
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- December 29, 2021
- Posted
- January 12, 2022
- Recall Number
- D-0358-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,965 100 count bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Out-of-specification impurity test result observed at 18-month long term stability time point.
Distribution
Product Distributed in NY and OH.
Lot / Code Info
Lot # S000268, Exp. date January 2022
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