Americaine Aerosol, Spray
FDA Recall NDC 63736-378
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Americaine (NDC 63736-378). A significant event, classified as Class I, was initiated on Dec 21, 2023 by Insight Pharmaceuticals Llc. The reported reason for this action was: "Chemical Contamination: presence of benzene"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Completed
Chemical Contamination: presence of benzene
Dec 21, 2023
Jan 24, 2024
34,704 cans
Recall Profile & Regulatory Data
Event ID
93691
Classification
Class I
Enforcement Status
Completed
Recalling Firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# 1A16420, exp. date 01/31/2025
Affected Packages Involved in this Recall
63736-378-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
