Insight Pharmaceuticals Issues Voluntary Nationwide Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray Due to the Presence of Benzene

Rhea-AI Summary

Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (ticker symbol not provided), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray due to low levels of benzene in the propellant, posing a potential risk of cancer. No serious adverse events have been reported related to this recall.

Insights

Pharmaceutical Regulatory Affairs Specialist

The voluntary recall of a pharmaceutical product due to contamination with a carcinogenic substance is a significant compliance and safety issue. The detection of benzene, a known human carcinogen, even at low levels in a lot of Americaine® 20% Benzocaine Topical Anesthetic Spray, necessitates immediate action due to the potential health risks associated with benzene exposure. The recall is a proactive measure to prevent consumer exposure to this hazardous substance, which can lead to serious health conditions such as leukemia and other blood disorders.

While the recall is limited to a single lot, the implications for Prestige Consumer Healthcare's business could be multifaceted. The immediate financial impact may include the costs associated with the recall process, consumer refunds, potential legal liabilities and the destruction of the contaminated products. Long-term effects could involve enhanced scrutiny by regulators, possible damage to brand reputation and the need for improved quality control measures to prevent future occurrences.

Financial Analyst

The market's reaction to a product recall can vary depending on the perceived impact on a company's future revenue and profitability. In this case, the recall affects only one lot of the Americaine® product, which may limit the financial impact. However, investors will be attentive to the company's next quarterly financial results for any signs of recall-associated costs and any potential litigation expenses. The recall could also lead to increased operational costs if additional safety measures are implemented to prevent future contamination.

It is important to monitor the company's response and any updates on the recall's breadth and consumer feedback. Effective crisis management and transparent communication can mitigate negative investor sentiment. Moreover, the company's stock performance will need to be evaluated in the context of its ability to manage this issue and maintain consumer trust in its products.

Consumer Safety Advocate

From a consumer safety perspective, the voluntary recall underscores the importance of rigorous quality control and the potential health risks posed by contaminants in pharmaceutical products. Benzene exposure is a serious health concern and the recall serves as a reminder of the need for continuous monitoring and testing of products to ensure consumer safety. The action taken by Insight Pharmaceuticals demonstrates a commitment to safety, but also raises questions about the adequacy of existing quality control processes.

Consumers affected by the recall are advised to discontinue use immediately and follow the company's instructions for product disposal and reimbursement. The absence of serious adverse events reported to date is reassuring, but consumers should remain vigilant and report any health issues potentially related to the product to healthcare providers and the FDA's MedWatch program.

TARRYTOWN, N.Y., Dec. 22, 2023 (GLOBE NEWSWIRE) -- 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 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.

• 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.

FAQ

Why is Insight Pharmaceuticals recalling Americaine® 20% Benzocaine Topical Anesthetic Spray?

Insight Pharmaceuticals is recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray due to low levels of benzene found in the propellant, posing a potential risk of cancer.

What are the potential risks associated with the recalled product?

Exposure to benzene, a human carcinogen, can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening.

How can consumers get a refund for the recalled 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 number.

What should consumers do if they have the recalled product?

Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. They should also contact their physician or healthcare provider if they have experienced any problems related to using this anesthetic product.

How can adverse reactions or quality problems with the recalled product be reported?

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.