PlainRecalls
FDA Drug Critical Class I Terminated

Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010

Reported: June 1, 2016 Initiated: December 9, 2015 #D-0883-2016

Product Description

Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010

Reason for Recall

Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.

Details

Units Affected
Unknown
Distribution
Nationwide
Location
Arlington, TX

Frequently Asked Questions

What product was recalled?
Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010. Recalled by Lucy's Weight Loss (dba. Waisted With Lucy). Units affected: Unknown.
Why was this product recalled?
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0883-2016.