Home / Recalls / Tolmar, Inc. / D-1300-2022

D-1300-2022 Class II Terminated

Recalled by Tolmar, Inc. — Fort Collins, CO

Recall Details

Product Type
Drugs
Report Date
August 10, 2022
Initiation Date
July 11, 2022
Termination Date
June 22, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1271 tubes

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

Reason for Recall

Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time

Distribution Pattern

distributed to 1 consignee in KY.

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

Other recalls by Tolmar, Inc.

  • D-1178-2023 Class III — Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Ster (September 12, 2023)
  • D-0282-2022 Class II — Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR In (November 8, 2021)
  • D-66402-001 Class III — Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sand (September 23, 2013)