Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
Reported: November 24, 2021 Initiated: October 1, 2021 #D-0242-2022
Product Description
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
Reason for Recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Details
- Recalling Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Units Affected
- 738,432 cans
- Distribution
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- Location
- Whippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 738,432 cans.
Why was this product recalled? ▼
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 24, 2021. Severity: Moderate. Recall number: D-0242-2022.
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