Elevated risk U.S. Food and Drug Administration

A1 Dietary Supplement A1 Slim recall: Unapproved new drug; tainted with sibutramine

Recall published 9+ years ago

Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine

A1 Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

What the notice says: Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

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
October 4, 2017
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
A1
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Dietary Supplement A1 Slim

What the company announced

Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.

These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established; therefore, subject to recall.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. To date, Kiriko, LLC. has not received any reports of adverse events related to this recall.

This tainted product is marketed as a weight loss dietary supplement and is packaged in a white plastic bottle containing 30 capsules with a white screw-on cap, barcode A105212014. The recall includes all lots of A1 Slim remaining within expiry. The product was distributed Nationwide via retail stores in Houston, TX and by mail-order (December 6, 2016-May 1, 2017).

A1 Slim is notifying its distributors and customers by telephone and mail and is arranging for return of all recalled products. Consumers and retailers that have A1 Slim which is being recalled should stop using and return the product to the place of purchase.

Consumers with questions regarding this recall can contact Kiriko, LLC. by phone at 832-228-3613 or e-mail at [email protected] on Monday-Friday, 8:00 AM to 4:30 PM, CST. 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 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • A1

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

A1 — The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  3. If someone does avoid it, stop serving it and check anything already cooked with it.
  4. Warn anyone else who eats from your kitchen, including schools and childminders.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: Consumers and retailers that have A1 Slim which is being recalled should stop using and return the product to the place of purchase.

Company contact: Kiriko, LLC — Consumers: 832-228-3613, [email protected]

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 A1 prescription & otc drugs recalled?

Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code A1. 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?

The notice says: Consumers and retailers that have A1 Slim which is being recalled should stop using and return the product to the place of purchase.

Where was the recalled product sold?

It was distributed nationwide.

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