Product Safety Recalls

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NAFTIFINE HYDROCHLORIDE Recall D-1300-2022

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

NAFTIFINE HYDROCHLORIDE Recall D-1300-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1300-2022
Event ID90580
BrandNAFTIFINE HYDROCHLORIDE
Generic NameNAFTIFINE HYDROCHLORIDE
ManufacturerNAFTIFINE HYDROCHLORIDE
Original Package?1
Active SubstanceNAFTIFINE HYDROCHLORIDE
Drug RouteTOPICAL
Distributiondistributed to 1 consignee in KY.
Quantity1271 tubes
Recall ReasonFailed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Drug ClassificationClass II
Drug Code Info20220810
Product NDC0115-1510
Recall Initiation Date20220711
Report Date20220810
Classification Date20220801
Address701 Centre Ave
Fort Collins, CO 80526-1843
United States
Recalling FirmTolmar, Inc.
Initial Notification Letter
Unique Ingredient Identifier25UR9N9041
Drug Application NumberANDA206165
Structured Product Labeling (SPL ID)eaabbf9e-b49d-4d23-bd49-8bc5aaee3967
Structured Product Labeling (SPL Set ID)aeddb909-5d6a-4737-95df-a4f058fba6b2
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