Insight Pharmaceuticals Issues Voluntary Nationwide Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray Due to the Presence of Benzene
Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), has initiated a voluntary recall of one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. The recall is prompted by a recent review conducted by the manufacturer and their third-party lab, revealing a low level of benzene in the propellant used to spray the product from the can. It is important to note that benzene is not listed as an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products.
Risk Statement: Benzene, classified as a human carcinogen, can be absorbed through inhalation, ingestion, and skin contact. Exposure to benzene may lead to cancers such as leukemia and blood cancer of the bone marrow, posing life-threatening risks. While the recalled lot shows trace levels of benzene, no serious adverse events have been reported to date. The recall is undertaken as a precautionary measure, and the company emphasizes that no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray are affected.
Product Details:
- Product: Americaine® 20% Benzocaine Topical Anesthetic Spray
- NDC: 63736-378-02
- Lot Code: 1A16420
- Expiration: 01/25
- Package Size: 2 oz / 57 g
The affected lot was distributed nationwide in the United States through a limited number of retailers and online.
Insight has promptly notified retailers through overnight mail to remove the recalled product from shelves, providing detailed instructions in the Drug Recall Notification. The company is offering reimbursement for consumers who have purchased Americaine® 20% Benzocaine Topical Anesthetic Spray from the affected lot. Consumers can contact Insight Pharmaceuticals for a full refund by providing a picture of the bottom of the can with the affected lot number. The contact methods include email at medicalaffairs@prestigebrands.com, the website, or by phone at (800) 344-7239, Monday – Friday 8:30-5:30 eastern time.
Consumers in possession of the recalled product are urged to stop using it immediately, take a picture of the bottom of the can, and appropriately discard the product. Individuals experiencing any problems related to the use of this anesthetic product are advised to contact their physician or healthcare provider.
No serious adverse events have been reported to date.
Adverse reactions or quality problems associated with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form. Complete and return it to the address on the pre-addressed form or submit it by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge and cooperation of the U.S. Food and Drug Administration.
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