# FDA recall D-1300-2022

> **Tolmar, Inc.** · Class II · drug recall initiated 2022-07-11.

## 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

## Distribution

distributed to 1 consignee in KY.

## Key facts

- **Recall number:** D-1300-2022
- **Recalling firm:** Tolmar, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-07-11
- **Report date:** 2022-08-10
- **Termination date:** 2023-06-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Collins, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1300-2022

## Citation

> AI Analytics. FDA recall D-1300-2022. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/D-1300-2022. Source: US FDA. Licensed CC0.

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