A1 Slim Dietary Supplement Recalled for Undeclared Unapproved Drug Ingredients
Kiriko, LLC. is recalling A1 Slim dietary supplements because FDA analysis found undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of undeclared unapproved drug ingredients.
Plain-English summary
Kiriko, LLC. is recalling A1 Slim, a dietary supplement sold in 30-count bottles of 350 mg capsules. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The FDA conducted an analysis of the product and found it contained undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine. Because of these undeclared ingredients, the product is considered an unapproved drug for which safety and efficacy have not been established.
The recall covers 700 bottles distributed nationwide. All lots remaining within their expiry dates are affected. Consumers should stop using the product and contact the manufacturer for instructions on disposal or return.
The recalled product
- Product
- A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, [email protected] Bar-Code A105212014
- Manufacturer
- Kiriko, LLC.
- Category
- Drug — Dietary Supplement
- Affected units
- 700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
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