Drug 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
D-1300-2022
Product summary
- Firm
- Tolmar, Inc.
- Event
- Event 90580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1271 tubes
- Official record key
drug-enforcement:D-1300-2022
Official wording
Reason: Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Code information: Lot #: a) 12070A, Exp 5/2023; 11801A, Exp 9/2022; b) 12386A, Exp 8/2023; 11800A, Exp 9/2022; c) 11940A, Exp 12/2022
Distribution pattern: distributed to 1 consignee in KY.
Derived failure modes
-
Potency or specification failure
Out-of-Specification