FDAFDA · Food and drugs·Recall number D-0358-2022
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
Published January 12, 2022 · Recall initiated: December 29, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out-of-specification impurity test result observed at 18-month long term stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OXYCODONE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product Distributed in NY and OH.
- UPC
- 0343386434015
- Lot
- Lot # S000268, Exp. date January 2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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