FDAJuly 11, 2022drug
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, Bridg...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
What to do
FDA enforcement status: Terminated
Brands named
tolmar
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.2023-09-12
- FDAClindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-682021-11-08
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