Tinactin Aerosol, Spray
FDA Recall NDC 11523-0165
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 11523-0165). A significant event, classified as Class II, was initiated on Oct 01, 2021 by Bayer Healthcare Llc. The reported reason for this action was: "cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with 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 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
4,990,860 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%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 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.
Batch or Lot Expiration Information
Lot# (a)TN0060U, TN0060V, TN0060W, EXP 7/31/2022; TN0060X, TN0060Y, TN0060Z, TN006CJ, TN006CK, TN006CM, TN00610, EXP 9/30/2022; TN006YW, EXP 10/31/2022; TN006MY, TN006YX, TN006YY, EXP 12/31/2022; TN007EN, TN007EP, TN007ER, EXP 2/28/2023; (b)CV016TH, CV016TJ, CV017D8, CV017D7, EXP 10/31/2021; CV017XS, EXP 11/30/2021; CV01980, CV019DS, EXP 12/31/2021; CV01A72, CV01A73, CV01AE6, EXP 1/31/2022; CV01AUA, CV01B1E, EXP 2/28/2022; CV01BNE, EXP 3/31/2022; CV01BVU, EXP 3/31/2022; CV01CT6, CV01CY1, EXP 4/30/2022; CV01D2G, EXP 5/31/2022; CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022; CV01E2W, CV01E2X, EXP 7/31/2022; CV01E2U, EXP 7/31/2022; CV01E2V, EXP 8/31/2022; TN001V6, EXP 11/30/2022; TN00243, EXP 12/31/2022; TN0024B, TN0024C, TN0024D, TN0024E, TN003C6, EXP 1/31/2023; TN00408, TN00409, TN0047J, TN0047K, TN0040A, EXP 4/30/2022, (c) CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022
Affected Packages Involved in this Recall
11523-0165-3Product
Class I Terminated
Chemical Contamination: presence of benzene
Oct 01, 2021
Nov 24, 2021
4,990,860 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%) 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.
Batch or Lot Expiration 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
Affected Packages Involved in this Recall
11523-0165-3Product
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.
