Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. ...
FDA Recall #D-0236-2024 — Class I — December 21, 2023
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
Reason for Recall
Chemical Contamination: presence of benzene
Recalling Firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Tarrytown, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
34,704 cans
Distribution
Nationwide in the USA
Code Information
Lot # 1A16420, exp. date 01/31/2025
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated