Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene

Rhea-AI Summary

Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company, has announced a voluntary recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid due to elevated levels of benzene found in two lots of the product. Benzene is classified as a human carcinogen, and exposure to it can result in life-threatening conditions. The recall affects specific lot codes of the product, and consumers are advised to stop using the product immediately and contact the company for a full refund. No serious adverse events have been reported to date.

Positive

• None.

Negative

• Elevated levels of benzene found in the product can potentially result in life-threatening conditions for consumers
• The recall affects specific lot codes of the product, indicating a limited scope of the issue

Insights

Pharmaceutical Quality Assurance Specialist

The voluntary recall of Insight Pharmaceuticals' TING® 1% Tolnaftate Athlete's Foot Spray due to elevated benzene levels is a significant quality control issue. Benzene, a known human carcinogen, has strict exposure limits set by regulatory agencies. The presence of benzene, even if unintended, poses serious health risks, including leukemia and other blood disorders. This recall demonstrates the critical importance of robust quality assurance processes within pharmaceutical manufacturing, particularly regarding the supply chain and the components used in product formulation, such as propellants.

For stakeholders, the immediate implications include potential financial impact due to the recall process, product returns and potential legal liabilities. Long-term implications could involve enhanced scrutiny by the FDA, possible changes in consumer trust and the need for improved quality control measures. The company's proactive response and communication with consumers and retailers, offering reimbursement, may mitigate some negative impacts and help maintain consumer confidence.

Healthcare Policy Analyst

The recall of a consumer healthcare product due to contamination with a carcinogen is a public health concern that may prompt regulatory bodies to re-evaluate current policies and standards for acceptable levels of contaminants in consumer products. The FDA's involvement in the recall process indicates regulatory oversight, but this incident could lead to discussions about more stringent regulations and testing requirements for consumer healthcare products, especially those using propellants or other components that could introduce toxic substances.

From a policy perspective, the recall might catalyze a review of industry-wide practices and potentially result in more rigorous safety standards. While this could increase manufacturing costs, it would aim to prevent similar incidents and ensure consumer safety. The case underscores the need for continuous monitoring and assessment of health risks associated with consumer products.

Consumer Safety Advocate

Consumer safety is paramount and the discovery of benzene in TING® 1% Tolnaftate Athlete's Foot Spray raises significant concerns. As a carcinogen, benzene's presence in any consumer product is alarming. This incident highlights the necessity for consumers to be vigilant about the products they use and for companies to be transparent about potential risks. It also emphasizes the importance of having clear and accessible channels for consumers to report adverse reactions or quality issues, as well as the need for companies to act swiftly in response to such reports.

Consumers affected by this recall are advised to discontinue use immediately and follow the company's instructions for product disposal and refund claims. The recall, while concerning, offers an opportunity for Insight Pharmaceuticals to reinforce its commitment to consumer safety by taking corrective actions and preventing future occurrences.

TARRYTOWN, N.Y., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid to the consumer level. A recent review by our manufacturer and their third-party lab found that samples from two lots of the product contained elevated levels of benzene. While benzene is not an ingredient in any Ting® Antifungal Spray products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid (either before or after these batch codes) and no other Ting® Antifungal Spray Liquid products 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.

TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid is packaged in blue and white aerosol cans with Lot codes located on the bottom of the can.

Samples of the recalled lots below have been found to contain elevated levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any Ting products.

Product	NDC	Lot Code	Expiration	Package Size
TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid	63736-819-05	0H50545	07/24	4.5 oz/128 g
TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid	63736-819-05	1G50645	06/25	4.5 oz/128 g

The affected TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid lots were 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 TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid marked with one of the lot codes 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 TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid 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.

No serious adverse events have been reported to date.

Consumers with questions regarding this recall 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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this antifungal product.

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/4e67b6ae-69a2-4b42-aee6-cff9f651a24a

FAQ

What company is recalling the TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid?

Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company, is recalling the product.

What is the reason for the recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid?

Elevated levels of benzene were found in two lots of the product, leading to the recall.

What is the potential risk associated with the elevated levels of benzene in TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid?

Exposure to benzene can result in life-threatening conditions, as it is classified as a human carcinogen.

How can consumers affected by the recall get a refund for TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid?

Consumers can contact Insight Pharmaceuticals for a full refund by providing a picture of the bottom of the can with the affected lot number.

Are there any serious adverse events reported due to the recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid?

No serious adverse events have been reported to date.