FDA Recall D-0236-2024
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company · Tarrytown, NY
Class I — life-threatening Completed 875 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Chemical Contamination: presence of benzene
Recall record
- Recall number
D-0236-2024- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-12-21
- Classified by FDA Center
- 2024-01-17
- FDA published
- 2024-01-24
- Recalling firm
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
- Firm location
- Tarrytown, NY
Drug identification
- Brand name(s)
- AMERICAINE
- Generic name(s)
- BENZOCAINE
- Manufacturer(s)
- Insight Pharmaceuticals LLC
- NDC(s)
63736-378- Route(s)
- TOPICAL