Recalls / Class III
Class IIID-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
- Brand name
- Oxycodone Hydrochloride
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDCs
- 43386-430, 43386-432, 43386-433, 43386-434, 43386-431
- FDA application
- ANDA204021
- Affected lot / code info
- Lot # S000268, Exp. date January 2022
Why it was recalled
Out-of-specification impurity test result observed at 18-month long term stability time point.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 23,965 100 count bottles
- Distribution pattern
- Product Distributed in NY and OH.
Timeline
- Recall initiated
- 2021-12-29
- FDA classified
- 2022-01-05
- Posted by FDA
- 2022-01-12
- Terminated
- 2022-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0358-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.