Drug product
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
D-1518-2019
Product summary
- Event
- Event 83350
- Status
- Terminated
- Classification
- Class III
- Quantity
- 33,939 tubes
- Official record key
drug-enforcement:D-1518-2019
Official wording
Reason: Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Code information: Lot #: K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out-of-specification