Reported Jul 31, 2019 · Terminated
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin…
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. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
- Manufactured by
Lupin Limited Pithampur (M.P.) 454 775 INDIANDC 68180-545-01
- Lot codes and dates
Lot #: K800245Exp. Dec 2019K900036 Exp. Sep 20K900153Exp. 09/2020
- Amount recalled
- 33,939 tubes
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
- Nationwide
Why it was recalled
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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