Reported Aug 10, 2022 · Terminated
Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with
Tolmar, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tolmar, Inc. · 701 Centre Ave · Fort Collins, CO · 80526-1843
Is this the product you have?
Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Net Wt. 90g tube (NDC 0115-1510-48) |
| 2 | Net Wt. 40g tube (NDC 0115-1510-63) |
| 3 | 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 |
- Lot codes and dates
Lot #: a) 12070AExp 5/202311801AExp 9/2022b) 12386AExp 8/202311800AExp 9/2022c) 11940AExp 12/2022
- Amount recalled
- 1271 tubes
Where it was sold
Why it was recalled
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
This product could cause temporary or reversible health problems — stop using it.
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