Podactin FDA Alerts
The FDA Alerts below may be specifically about Podactin or relate to a group or class of drugs which include Podactin.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Podactin
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene
TARRYTOWN, N.Y.--(GLOBE NEWSWIRE)-February 1, 2024—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 Number |
Expiration Date |
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
- Regular Mail or Fax: Download form 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.
Source: FDA