Recalls / Class II
Class IID-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
- Affected lot / 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
Why it was recalled
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Recalling firm
- Firm
- Tolmar, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 701 Centre Ave, N/A, Fort Collins, Colorado 80526-1843
Distribution
- Quantity
- 1271 tubes
- Distribution pattern
- distributed to 1 consignee in KY.
Timeline
- Recall initiated
- 2022-07-11
- FDA classified
- 2022-08-01
- Posted by FDA
- 2022-08-10
- Terminated
- 2023-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1300-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.