Drug product
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
D-0257-2026
Product summary
- Event
- Event 98062
- Status
- Ongoing
- Classification
- Class III
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0257-2026
Official wording
Reason: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Code information: Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of Specification