Skip to content
Recall Observatory FDA recall evidence

Drug 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.

D-0251-2022

October 01, 2021

Class I

Product summary

Firm
Bayer Healthcare Pharmaceuticals Inc.
Event
Event 88677
Status
Terminated
Classification
Class I
Quantity
4,990,860 cans
Official record key
drug-enforcement:D-0251-2022

Official wording

Reason: Chemical Contamination: presence of benzene

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

Distribution pattern: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination