FDA 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.

Distribution

Product Distributed in NY and OH.

Key facts

Status

Terminated

Initiation date

2021-12-29

Report date

2022-01-12

Termination date

2022-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0358-2022