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Class I: serious health riskCompleted

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare Americaine Recall

Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57…

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Tarrytown, NY

Risk level
Class I
Reported by FDA
Jan 24, 2024
Recall ID
D-0236-2024
Check your lot numberHow we source this data

Summary

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare recalled Americaine starting Dec 21, 2023. The FDA classified it as Class I (serious health risk) and published enforcement report D-0236-2024 on Jan 24, 2024. Reason: Chemical Contamination: presence of benzene. Status: Completed.

Why it was recalled

Chemical Contamination: presence of benzene

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0236-2024
Classification
Class I
Status
Completed
Recall initiated
Dec 21, 2023
FDA report date
Jan 24, 2024
Quantity
34,704 cans
Recall type
Voluntary: Firm initiated
Recalling firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Original FDA data

Every field from FDA enforcement report D-0236-2024, exactly as published.

Show all FDA fields
City
Tarrytown
State
NY
Status
Completed
Country
United States
Event ID
93691
Address
660 White Plains Rd Ste 250
Code information
Lot # 1A16420, exp. date 01/31/2025
Postal code
10591-5171
Report date
Jan 24, 2024
Product type
Drugs
Recall number
D-0236-2024
Classification
Class I
Recalling firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Product quantity
34,704 cans
Reason for recall
Chemical Contamination: presence of benzene
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the USA
Recall initiation date
Dec 21, 2023
Initial firm notification
Letter
Center classification date
Jan 17, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0236-2024, published Jan 24, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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