FDA Drug recall 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 0115-1510-6…
- FDA Drug
- Class II
- terminated
- Published 2022-08-10
On 2022-08-10 the FDA classified a Class II recall of Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC 0115-1510-48), b) Net Wt. 40g tube (NDC 0115-1510-6… by Tolmar, citing failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1300-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-11 |
| Published | 2022-08-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tolmar |
| Distribution | KY |
Product
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
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1300-2022%22
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