Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent. drug
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8.
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 Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
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.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.