# FDA recall D-0058-2018

> **Kiriko, LLC.** · Class II · drug recall initiated 2017-10-06.

## Product

A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584,  www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014

## Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared  sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0058-2018
- **Recalling firm:** Kiriko, LLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-10-06
- **Report date:** 2017-11-08
- **Termination date:** 2020-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Manvel, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0058-2018

## Citation

> AI Analytics. FDA recall D-0058-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0058-2018. Source: US FDA. Licensed CC0.

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