Drug product
Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
D-0116-2017
Product summary
- Event
- Event 75349
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,576 units
- Official record key
drug-enforcement:D-0116-2017
Official wording
Reason: Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Code information: Lot #: B5093-18608, B5094-18608, Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017
Distribution pattern: US & Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications