Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene
2024年2月2日 - 11:00PM
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
Investor Relations Contact
Phil Terpolilli, CFA, 914-524-6819
irinquiries@prestigebrands.com
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