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.
Reported: November 24, 2021 Initiated: October 1, 2021 #D-0245-2022
Product Description
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.
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
- 2,841,012 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%) 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.. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 2,841,012 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-0245-2022.
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