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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1300-2022 |
| Event ID | 90580 |
| Brand | NAFTIFINE HYDROCHLORIDE |
| Generic Name | NAFTIFINE HYDROCHLORIDE |
| Manufacturer | NAFTIFINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | NAFTIFINE HYDROCHLORIDE |
| Drug Route | TOPICAL |
| Distribution | distributed to 1 consignee in KY. |
| Quantity | 1271 tubes |
| Recall Reason | Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time |
| Drug Classification | Class II |
| Drug Code Info | 20220810 |
| Product NDC | 0115-1510 |
| Recall Initiation Date | 20220711 |
| Report Date | 20220810 |
| Classification Date | 20220801 |
| Address | 701 Centre Ave Fort Collins, CO 80526-1843 United States |
| Recalling Firm | Tolmar, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 25UR9N9041 |
| Drug Application Number | ANDA206165 |
| Structured Product Labeling (SPL ID) | eaabbf9e-b49d-4d23-bd49-8bc5aaee3967 |
| Structured Product Labeling (SPL Set ID) | aeddb909-5d6a-4737-95df-a4f058fba6b2 |
| Similar To |