July 2022 FDA Recall Drug by Tolmar, Inc.
D-1300-2022 - Failed Impurities/ degradation specifications

This Class II drug recall was voluntarily initiated by Tolmar, Inc. on July 11, 2022 for the product Drug. The FDA reported the reason for recall as failed impurities/ degradation specifications. The product was distributed in distributed to 1 consignee in KY. and the recall is currently terminated.

Recall Number: D-1300-2022

Reason for Recall
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Initiated
07-11-2022
Reported
08-10-2022
Quantity
1271 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90580
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tolmar, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
distributed to 1 consignee in KY.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-22-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration 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