Highest risk U.S. Food and Drug Administration

Super Panther 7K Dietary Supplement recall: Unapproved new drug

Recall published 9+ years ago

Unapproved new drug

Super Panther 7K Dietary supplements — recalled dietary supplementsSuper Panther 7K Dietary supplements — recalled dietary supplements (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: 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.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
July 21, 2017
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Super Panther 7K
Product type
Dietary supplements
Distribution
Nationwide
UPC codes
601577513209, 6015577513247, 015577513247

Products covered by this recall

Dietary Supplement

What the company announced

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

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 601577513209
  • 6015577513247
  • 015577513247

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • RO846356
  • RO246852
  • RO246852 1-count

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 8/28/2020
  • 08/28/2020

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 count
  • 6 count
  • 30 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Super Panther 7K — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Ultra Shop Supplement — Consumers: 888-246-9664

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Super Panther 7K dietary supplements recalled?

Unapproved new drug 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 601577513209, 6015577513247, 015577513247; lot code RO846356, RO246852, RO246852 1-count; best-by date 8/28/2020 or 08/28/2020. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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