FDA-Drug2021-11-24Class II
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Bayer Healthcare Pharmaceuticals Inc.
Hazard
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Sold states
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Affected count
2,841,012 cans
Manufactured in
100 Bayer Blvd, N/A, Whippany, NJ, United States
Products
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2022Don't want to check this manually?
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