Insight Pharmaceuticals is recalling 2 lots of TING^® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder due to the presence of benzene.

The issue was identified during a review of samples that showed elevated levels of benzene, a human carcinogen, in the product. The Company noted that the benzene came from the propellant that sprays the product out of the can and is not an ingredient in TING products. The recall is being conducted out of an abundance of caution; there have been no reports of adverse events related to the use of the product thus far.

The affected lots include Lot# 0H88645 (expiration date 7/24; package size 4.5oz) and Lot# 0B88345 (expiration date 2/24; package size 4.5oz). The recalled products were distributed nationwide through a limited number of retailers and online. The recall only affects these 2 lots and does not affect any other TING antifungal spray products.

Consumers that have the affected product should stop use immediately. To obtain a refund, consumers can contact Insight Pharmaceuticals at 800-344-7239, via email at medicalaffairs@prestigebrands.com, or through its website. 

Adverse reactions related to this recall should be reported to the FDA’s MedWatch program, as well as to the Company.

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum. 

Berdazimer gel is an investigational nitric oxide-releasing topical antiviral gel. The application is supported by data from the pivotal phase 3 B-SIMPLE4 study (ClinicalTrials.gov Identifier: NCT04535531) that evaluated the efficacy and safety of berdazimer gel 10.3% applied topically once daily in 891 patients 6 months of age and older with molluscum contagiosum.

Findings from the trial showed that treatment with berdazimer gel met the primary endpoint achieving complete clearance of all treatable molluscum lesions at week 12 compared with vehicle gel. As for safety, berdazimer gel was well tolerated with no treatment-related serious adverse events reported. The most common adverse events reported were mild application site pain and mild to moderate erythema.

A Prescription Drug User Fee Act target date of January 5, 2024 has been set for this application.

Reference

FDA accepts Novan’s NDA for Berdazimer Gel, 10.3% for the treatment of molluscum contagiosum with a PDUFA Goal Date of January 5, 2024. News release. Novan. Accessed March 7, 2023. https://www.globenewswire.com/news-release/2023/03/07/2622009/0/en/FDA-Accepts-Novan-s-NDA-for-Berdazimer-Gel-10-3-for-the-Treatment-of-Molluscum-Contagiosum-with-a-PDUFA-Goal-Date-of-January-5-2024.html.

HealthDay News — Patients may be tempted to treat little skin bumps on their own, but that can delay proper diagnosis and treatment that may work better, federal regulators caution.

Products marketed as treatments for molluscum have not been approved by the US Food and Drug Administration, the agency warned. There are no approved treatments in either prescription or over-the-counter form for the condition, which will typically go away on its own in 6 to 12 months but could last up to 5 years.

Molluscum can grow alone or in groups almost anywhere on the skin, including the face, neck, arms, legs, abdomen, and genital area. They are rarely on the palms of the hands or soles of the feet. Sometimes these bumps itch and get irritated. Patients with a weakened immune system may have larger or more bumps. They are more common in children, but can happen in teens and adults.

Molluscum is spread by skin-to-skin contact, including sexual contact, and by sharing clothes or infected objects such as sports equipment. Staying clean, including hand washing, is the best way to prevent them.

Unapproved products are unlikely to actually have the impact they claim and may cause bad reactions, such as skin reddening, abrasion from skin scratching, and permanent scarring. It is also possible to have an allergic reaction to products, such as those that contain essential oils.

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