Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufact...
FDA Recall #D-1518-2019 — Class III — July 17, 2019
Product Description
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
Reason for Recall
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
33,939 tubes
Distribution
Nationwide within the United States
Code Information
Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated