FDA recall D-1300-2022

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 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.

Key facts

Status

Terminated

Initiation date

2022-07-11

Report date

2022-08-10

Termination date

2023-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Collins, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1300-2022