Tinactin Aerosol, Powder
FDA Recall NDC 11523-4162
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Tinactin (NDC 11523-4162). A significant event, classified as Class I, was initiated on Oct 01, 2021 by Bayer Healthcare Llc.. The reported reason for this action was: "Chemical Contamination: presence of benzene"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Chemical Contamination: presence of benzene
Oct 01, 2021
Nov 24, 2021
738,432 cans
Recall Profile & Regulatory Data
Event ID
88677
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Bayer Healthcare Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Termination Date
Jun 26, 2023
Product Description
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
Batch or Lot Expiration Information
Lot# TN0067A, EXP 2/28/2023; TN008CU, EXP 4/30/2023
Affected Packages Involved in this Recall
11523-4162-1Product
Class II Terminated
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Oct 01, 2021
Nov 24, 2021
738,432 cans
Recall Profile & Regulatory Data
Event ID
88677
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Bayer Healthcare Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Termination Date
Jun 26, 2023
Product Description
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
Batch or Lot Expiration Information
Lot# (a) TN004BW, EXP 7/31/2022, (b) TN00678, EXP 8/31/2022; TN00679, EXP 9/30/2022
Affected Packages Involved in this Recall
11523-4162-1Product
11017-410-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
