Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceutic
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Summary
The FDA issued a Class I for Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company. Reason: Chemical Contamination: presence of benzene.
Details
Source
Drug Recall
External ID
D-0236-2024
Action Date
2024-01-24
Status
Completed
Category
drug
Product Description
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7
Lot/Code Info: Lot # 1A16420, exp. date 01/31/2025
Quantity Affected: 34,704 cans
Reason for Recall
Chemical Contamination: presence of benzene
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
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 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company has 2 FDA actions in our database, including 2 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 (Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company have FDA actions?
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0236-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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