Drug recall D-0358-2022
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.
Lots and codes
Lot # S000268, Exp. date January 2022
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 23,965 100 count bottles
- Distribution
- Product Distributed in NY and OH.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 29, 2021
- Terminated
- August 23, 2022
Related products
- Oxycodone Hydrochloride – drug information
- NDC 43386-431 Oxycodone Hydrochloride · Oxycodone Hydrochloride 30 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-434 Oxycodone Hydrochloride · Oxycodone Hydrochloride 20 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-430 Oxycodone Hydrochloride · Oxycodone Hydrochloride 15 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-432 Oxycodone Hydrochloride · Oxycodone Hydrochloride 5 mg/1 · Lupin Pharmaceuticals,Inc.
- NDC 43386-433 Oxycodone Hydrochloride · Oxycodone Hydrochloride 10 mg/1 · Lupin Pharmaceuticals,Inc.