FDA recall D-0236-2024

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Class I · drug

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

Reason for recall

Chemical Contamination: presence of benzene

Distribution

Nationwide in the USA

Key facts

Status
Completed
Initiation date
2023-12-21
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0236-2024