Lotrimin Daily Prevention Deo Aerosol, Powder
FDA Recall NDC 11523-0010
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Lotrimin Daily Prevention Deo (NDC 11523-0010). 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
77,076 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
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.
Batch or Lot Expiration Information
Lot# TN005K4, EXP 4/30/2022; TN005K8, EXP 6/30/2022
Affected Packages Involved in this Recall
11523-0010-1Product
11523-0010-2Product
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
579,456 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
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,
Batch or Lot Expiration Information
Lot# (a)TN0023C, EXP 1/31/2022; TN003C7, EXP 4/30/2022; TN00570, EXP 7/31/2022; TN0056Z, TN005KJ, EXP 8/31/2022; (b)TN0023C, EXP 01/31/2022; TN003C7, EXP 04/30/2022; TN0023DV, TN0023DAV, TN0023DBV, TN0023DC, EXP 02/28/2022; TN005KJ, TN005KJA, TN005KJB, EXP 08/31/2022
Affected Packages Involved in this Recall
11523-0010-1Product
11523-0010-2Product
Class II Terminated
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Oct 01, 2021
Nov 24, 2021
579,456 units
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
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2
Batch or Lot Expiration Information
Lot# NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022
Affected Packages Involved in this Recall
11523-0010-1Product
11523-0010-2Product
0004110059Product
Class I Terminated
Chemical Contamination: presence of benzene
Oct 01, 2021
Nov 24, 2021
579,456 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
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.
Batch or Lot Expiration Information
Lot# TN0023D, EXP 2/28/2022; TN004BX, EXP 6/30/2022
Affected Packages Involved in this Recall
11523-0010-1Product
11523-0010-2Product
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.
