Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
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 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Reason Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
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