December 2023 FDA Recall Americaine by Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company
D-0236-2024 - Chemical Contamination

This Class I drug recall was voluntarily initiated by Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company on December 21, 2023 for the product Americaine. The FDA reported the reason for recall as chemical contamination. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0236-2024

Reason for Recall
Chemical Contamination: presence of benzene
Initiated
12-21-2023
Reported
01-24-2024
Quantity
34,704 cans

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93691
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

63736-378-02 Americaine