FDA Recall D-0251-2022

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%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

Lot / code: Lot # (a)TN006MX, EXP 10/31/2022; TN00BKV, TN008D1, TN008D2, EXP 3/31/2023; (b) CV0180B, EXP12/31/2021; TN003C5, EXP 1/31/2023

Quantity: 4,990,860 cans

Reason for recall

Chemical Contamination: presence of benzene

Recall record

Recall number: D-0251-2022
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): 11523-0165
Route(s): TOPICAL

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