Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective Container: Firm received complaints of broken tube at the seal.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Reason Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Reason Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
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