FDA Recall D-0250-2022
Bayer Healthcare Pharmaceuticals Inc. · Whippany, NJ
Class I — life-threatening Terminated 633 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105
Reason for recall
Chemical Contamination: presence of benzene
Recall record
- Recall number
D-0250-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- Recall initiated
- 2021-10-01
- Classified by FDA Center
- 2021-11-18
- FDA published
- 2021-11-24
- Terminated
- 2023-06-26
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Firm location
- Whippany, NJ
Drug identification
- Brand name(s)
- TINACTIN
- Generic name(s)
- TOLNAFTATE
- Manufacturer(s)
- Bayer HealthCare LLC.
- NDC(s)
11523-4162- Route(s)
- TOPICAL