D-0236-2024 Class I

Recalled by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Tarrytown, NY

FDA drug recall D-0236-2024 was initiated by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company on December 21, 2023 and is designated Class I. Reason for recall: Chemical Contamination: presence of benzene Affected quantity: 34,704 cans.

Recall Details

Product Type
Drugs
Report Date
January 24, 2024
Initiation Date
December 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,704 cans

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 1A16420, exp. date 01/31/2025