Lupin Pharmaceuticals Inc. recalls Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Recalled January 12, 2022 · FDA recall D-0358-2022 · Lupin Pharmaceuticals
Hazard
Out-of-specification impurity test result observed at 18-month long term stability time point. · FDA Class III
Units
23,965 100 count bottles
Sold at
Product Distributed in NY and OH.
Description
Out-of-specification impurity test result observed at 18-month long term stability time point.
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
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →