Class I · High risk Completed
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight…
Reason Chemical Contamination; presence of benzene.
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
What was recalled
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
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- NDC code
- 11523-0072-5
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0244-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Tolnaftate recalls
See all
Class II · Moderate risk Completed
Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class I · High risk Terminated
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and…
Reason Chemical contamination: Presence of benzene
Class II · Moderate risk Terminated
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC…
Reason cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Class I · High risk Terminated
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of…
Reason Chemical Contamination: presence of benzene
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