Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
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.
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