PlainRecalls
FDA Drug Critical Class I Terminated

Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010

Reported: June 1, 2016 Initiated: September 23, 2015 #D-0880-2016

Product Description

Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010

Reason for Recall

Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.

Details

Units Affected
Unknown
Distribution
Nationwide
Location
Arlington, TX

Frequently Asked Questions

What product was recalled?
Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 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 and phenolphthalein.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0880-2016.