D-1518-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2019
- Initiation Date
- July 17, 2019
- Termination Date
- September 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,939 tubes
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020