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, Distrib

FDA recall notice · announced August 10, 2022 · Tolmar

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: distributed to 1 consignee in KY.
Lot/code information: Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022
Quantity: 1271 tubes
Status: Terminated
Products in this recall event:
- 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, Manufact (D-1300-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.