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Recall Observatory FDA recall evidence

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

D-0236-2024

December 21, 2023

Class I

Product summary

Firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Event
Event 93691
Status
Completed
Classification
Class I
Quantity
34,704 cans
Official record key
drug-enforcement:D-0236-2024

Official wording

Reason: Chemical Contamination: presence of benzene

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Chemical Contamination