TOPIC: Americaine 20% Benzocaine Topical Anesthetic Spray by Insight Pharmaceuticals: Recall - Due to the Presence of Benzene
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: Insight Pharmaceuticals is recalling one lot, 1A16420, of Americaine 20% Benzocaine Topical Anesthetic Spray. While benzene is not an ingredient in any Americaine 20% Benzocaine Topical Anesthetic Spray products, a recent review by the 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 lot 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. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. The affected Americaine 20% Benzocaine Topical Anesthetic Spray lot was distributed nationwide in the United States through a limited number of retailers and online.
To date, the company has not received any serious adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The recalled product is used for minor cuts, scrapes, burns and sunburns. 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.
RECOMMENDATIONS:
- Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this anesthetic product.
- Consumers can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.com, through its website at https://www.prestigebrands.com/contact, or by phone at (800) 344-7239 to receive a full refund by providing a picture of the bottom of the can of the Americaine 20% Benzocaine Topical Anesthetic Spray with the affected lot code.
- Consumers that have the product which is being recalled should stop using the product immediately and appropriately discard after taking a picture.
- Insight has notified retailers via overnight mail to remove any remaining recalled product from the shelves and to follow the instructions provided in the Drug Recall Notification.
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