FDA-Drug2022-01-12Class III
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
Lupin Pharmaceuticals Inc.
Hazard
Out-of-specification impurity test result observed at 18-month long term stability time point.
Sold states
Product Distributed in NY and OH.
Affected count
23,965 100 count bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0358-2022Don't want to check this manually?
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