Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 079
Summary
The FDA issued a Class I for Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by by Bayer Healthcare Pharmaceuticals Inc.. Reason: Chemical Contamination: presence of benzene.
Details
Source
Drug Recall
External ID
D-0252-2022
Action Date
2021-11-24
Status
Terminated
Category
drug
Product Description
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
Lot/Code Info: Lot # TN008M0, EXP 4/30/2023
Quantity Affected: 592,416 cans
Reason for Recall
Chemical Contamination: presence of benzene
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-01
Company
Whippany, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 178 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Bayer Healthcare Pharmaceuticals Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bayer Healthcare Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bayer Healthcare Pharmaceuticals Inc. have FDA actions?
Bayer Healthcare Pharmaceuticals Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0252-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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