Recalls / Class I
Class ID-0236-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Americaine
- Generic name
- Benzocaine
- Active ingredient
- Benzocaine
- Route
- Topical
- NDC
- 63736-378
- FDA application
- M017
- Affected lot / code info
- Lot # 1A16420, exp. date 01/31/2025
Why it was recalled
Chemical Contamination: presence of benzene
Recalling firm
- Firm
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
- Manufacturer
- Insight Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 660 White Plains Rd Ste 250, N/A, Tarrytown, New York 10591-5171
Distribution
- Quantity
- 34,704 cans
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-12-21
- FDA classified
- 2024-01-17
- Posted by FDA
- 2024-01-24
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0236-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.