Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and Tadalafil
- Company Announcement Date:
- July 21, 2017
- FDA Publish Date:
- February 08, 2018
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Recall Reason DescriptionUnapproved new drug
- Company Name:
- Ultra Shop Supplement
- Brand Name:
Brand Name(s)Super Panther 7K
- Product Description:
Product DescriptionDietary Supplement
Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, (1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry), distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (PDE-5), used to treat erectile dysfunction (ED). The presence of sildenafil and tadalafil in Super Panther 7K renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
Consumers who take this product for erectile dysfunction could have underlying cardiovascular disease. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse. To date, Ultra Shop Supplement has not received any reports of adverse events related to this recall.
Super Panther 7K is marketed as a dietary supplement for sexual enhancement and packaged in Super Panther 7K capsules, 6-count bottles UPC 6 01577 51320 9, Exp 8/28/2020 lot RO246852 1-count blister cards UPC 6 015577 51324 7, and 30-count hanging card display UPC 015577 51324 7, and lot RO846356, Exp 08/28/2020. Super Panther 7K was sold to consumers nationwide in the USA via our retail website. Ultra Shop Supplements has discontinued sales of these products and has notified its customers of this voluntary recall via e-mail.
Consumers that purchased these products from Ultra Shop directly, should stop using them immediately and can contact us at 888-246-9664 Monday-Friday between the hours of (9:00 am to 5:00 pm Eastern time) and request to return the recalled products. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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
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