D-0239-2022 Class II Terminated
FDA drug recall D-0239-2022 was initiated by Bayer Healthcare Pharmaceuticals Inc. on October 1, 2021 and is designated Class II. Reason for recall: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. The recall status is terminated (terminated June 26, 2023). Affected quantity: 77,076 cans.
Recall Details
- Product Type
- Drugs
- Report Date
- November 24, 2021
- Initiation Date
- October 1, 2021
- Termination Date
- June 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77,076 cans
Product Description
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.
Reason for Recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Distribution Pattern
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Code Information
Lot # TN005K4, EXP 4/30/2022; TN005K8, EXP 6/30/2022