Insight Pharmaceuticals Issues Voluntary Nationwide Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray Due to the Presence of Benzene
TARRYTOWN, N.Y., Dec. 22, 2023 (GLOBE NEWSWIRE) -- Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine®
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 recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.
Americaine®
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® Benzocaine Topical Anesthetic Spray | 63736-378-02 | 1A16420 | 01/25 | 2 oz / 57 g |
The affected Americaine®
Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased Americaine®
No serious adverse events have been reported to date.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b32d23b6-9edf-47e7-9c8d-2f763b65b560.
