FDAFDA · Food and drugs·Recall number D-1300-2022
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
Published August 10, 2022 · Recall initiated: July 11, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tolmar, Inc.
- Distributor
- distributed to 1 consignee in KY.
- Lot
- Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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