Drug Enforcement D-0236-2024

Chemical Contamination: presence of benzene

Status

Completed

Classification

Class I

Report Date

January 24, 2024

Termination Date

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Product Information

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
Product quantity
34,704 cans
Reason for recall
Chemical Contamination: presence of benzene
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Address
660 White Plains Rd Ste 250, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0236-2024
Event ID
93691
Recall initiation date
December 21, 2023
Center classification date
January 17, 2024
Code info
Lot # 1A16420, exp. date 01/31/2025
More code info
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