D-0249-2018 Class III Terminated
FDA drug recall D-0249-2018 was initiated by Taro Pharmaceuticals U.S.A., Inc. on December 21, 2017 and is designated Class III. Reason for recall: Failed Content Uniformity Specifications The recall status is terminated (terminated September 21, 2020). Affected quantity: 27,792 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- December 21, 2017
- Termination Date
- September 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27,792 tubes
Product Description
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
Reason for Recall
Failed Content Uniformity Specifications
Distribution Pattern
Nationwide
Code Information
Lot 311235, exp Sept 2018