Drug product
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
D-0727-2022
Product summary
- Event
- Event 89678
- Status
- Terminated
- Classification
- Class III
- Quantity
- 768 tubes
- Official record key
drug-enforcement:D-0727-2022
Official wording
Reason: Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Code information: Lot #: AC33883, Exp. Date June 2023
Distribution pattern: Product was distributed to one retail consignee in NY.
Derived failure modes
-
Potency or specification failure
Out-of-specification