Product: Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-63), c)  Net Wt. 60g tube (NDC 0115-1510-58), Rx only, Manufactured by: Tolmar, Inc., Fort Collins, CO, 80526, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Reason for recall: Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Recall initiated: 20220711
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated