Drug product
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
D-0240-2026
Product summary
- Firm
- SUN PHARMA /TARO
- Event
- Event 98104
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,664 units
- Official record key
drug-enforcement:D-0240-2026
Official wording
Reason: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Code information: Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation specifications