Tolmar, Inc.: Drug Recall
Recall #D-1300-2022 · 07/11/2022
Class II: Risk
Recall Details
- Recall Number
- D-1300-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Tolmar, Inc.
- Status
- Terminated
- Date Initiated
- 07/11/2022
- Location
- Fort Collins, CO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1271 tubes
Reason for Recall
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Product 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
Distribution Pattern
distributed to 1 consignee in KY.
Other Recalls by Tolmar, Inc.
- Class III: Low Risk 09/12/2023
- Class II: Risk 11/08/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.