Last Updated on January 8, 2024 by The Health Master
Drug recall
Drug recall: Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level.
While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can.
Importantly, no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray (either before or after this batch code) are in the scope of this recall and may continue to be used by consumers safely and as intended.
Risk Statement:
Benzene is classified as a human carcinogen.
Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening.
Insight is recalling these products out of an abundance of caution.
To date, the Company has not received any serious adverse events related to this drug recall.
Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.
Americaine® 20% Benzocaine Topical Anesthetic Spray is packaged in white aerosol cans with Teal caps with Lot codes located on the bottom of the can.
Samples of the recalled lot below have been found to contain trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Americaine products.
| Product | NDC | Lot Code | Expiration | Package Size |
|---|---|---|---|---|
| Americaine® 20% Benzocaine Topical Anesthetic Spray | 63736-378-02 | 1A16420 | 01/25 | 2 oz / 57 g |
The affected Americaine® 20% Benzocaine Topical Anesthetic Spray lot was distributed nationwide in the United States through a limited number of retailers and online.
No serious adverse events have been reported to date.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
Drug recall: Unraveling the recall by Sun and Lupin
Drug recall: Vigabatrin for Oral Solution recalled – A closer look
Drug recall: Antifungal Spray Powder Due to the Presence of Benzene
Drug recall: Glenmark, Sun recalled these Drugs
Drug recall: Sandimmune Oral Solution Voluntary Recalled: Novartis
DCA Telangana’s Battle Against Spurious Drugs
USFDA issued Form 483 with 5 observations to Torrent
National Single Window System for Medical Devices
Unveiling the Top 20 Most Expensive Drugs in the World
The Need for Parallel Drug Approval in India: OPPI’s Urgent Plea
National Human Rights Commission’s Inquiry into Medicines Standards
India’s First Child-Friendly Chemotherapy Drug Developed
USFDA approval granted for Posaconazole Injection
NPPA Recommends Retail Prices for Anti Diabetes Drug Combinations
USFDA approval granted for Loteprednol Etabonate Ophthalmic Suspension
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
