Bayer Healthcare Pharmaceuticals Inc.: Drug Recall

Recall #D-0254-2022 · 10/01/2021

Class II: Risk

Recall Details

Recall Number
D-0254-2022
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
579,456 units

Reason for Recall

cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.

Product Description

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2

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.