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SUN PHARMA /TARO: Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10

DrugsSource: FDA (drug) · Date: 2025-12-24

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
SUN PHARMA /TARO
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
Reason / hazard
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2025-12-09
Code info
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Product quantity
17,664 units
Voluntary mandated
Voluntary: Firm initiated
City
Hawthorne
State
NY
Country
United States
Event id
98104
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