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
Reported: January 12, 2022 Initiated: December 29, 2021 #D-0358-2022
Product Description
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 23,965 100 count bottles
- Distribution
- Product Distributed in NY and OH.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 23,965 100 count bottles.
Why was this product recalled? ▼
Out-of-specification impurity test result observed at 18-month long term stability time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 12, 2022. Severity: Low. Recall number: D-0358-2022.
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