Class II
Terminated
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
- Company
- Tolmar, Inc.
- Recall Initiated
- July 11, 2022
- Posted
- August 10, 2022
- Recall Number
- D-1300-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1271 tubes
- Firm Location
- Fort Collins, CO, United States
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.
Lot / Code Info
Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022
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