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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Prestige Consumer Healthcare Inc | NYSE:PBH | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.28 | 0.40% | 70.68 | 71.7772 | 70.38 | 71.02 | 222,395 | 01:00:00 |
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® 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.
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® 20% Benzocaine Topical Anesthetic Spray marked with the lot code in the table above. 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 on Monday – Friday 8:30-5:30 eastern time 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 number. Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this anesthetic product.
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.
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.
Investor Relations Contact Phil Terpolilli, CFA, 914-524-6819 irinquiries@prestigebrands.com
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