Tolmar, Inc. recalls Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g t…

Recall date

July 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1300-2022

FDA classification

Class II

Brand / firm

Tolmar, Inc.

Sold / distributed

distributed to 1 consignee in KY.

Why it was recalled

Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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