Bayer Healthcare Pharmaceuticals Inc.: Drug Recall

Recall #D-0243-2022 · 10/01/2021

Class II: Risk

Recall Details

Recall Number
D-0243-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Bayer Healthcare Pharmaceuticals Inc.
Status
Terminated
Date Initiated
10/01/2021
Location
Whippany, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,990,860 cans

Reason for Recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Product Description

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

Distribution Pattern

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Other Recalls by Bayer Healthcare Pharmaceuticals Inc.

View all recalls by Bayer Healthcare Pharmaceuticals Inc. →

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.