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
Reported: August 10, 2022 Initiated: July 11, 2022 #D-1300-2022
Product Description
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
Details
- Recalling Firm
- Tolmar, Inc.
- Units Affected
- 1271 tubes
- Distribution
- distributed to 1 consignee in KY.
- Location
- Fort Collins, CO
Frequently Asked Questions
What product 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. Recalled by Tolmar, Inc.. Units affected: 1271 tubes.
Why was this product recalled? ▼
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 10, 2022. Severity: Moderate. Recall number: D-1300-2022.
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