D-0244-2022 Class II Terminated
FDA drug recall D-0244-2022 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: 592,416 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
- 592,416 cans
Product Description
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
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 # TN00086, CV015YU, EXP 10/31/2022; TN00273, EXP 12/31/2022; TN005RW, Exp 5/31/2023;