FDA-Drug2019-07-31Class III
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
Lupin Pharmaceuticals Inc.
Hazard
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Sold states
Nationwide within the United States
Affected count
33,939 tubes
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1518-2019Don't want to check this manually?
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