Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lu...
FDA Recall #D-0358-2022 — Class III — December 29, 2021
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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
23,965 100 count bottles
Distribution
Product Distributed in NY and OH.
Code Information
Lot # S000268, Exp. date January 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated