FDA recall D-0058-2018

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

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

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