Reported Jan 12, 2022 · Terminated
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals,…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, MD 21202
- Manufactured byNovel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
- Lot codes and dates
Lot # S000268Exp. date January 2022
- Amount recalled
- 23,965 100 count bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Out-of-specification impurity test result observed at 18-month long term stability time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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