Home / Recalls / Lucy's Weight Loss (dba. Waisted With Lucy) / D-0881-2016

D-0881-2016 Class I Terminated

Recalled by Lucy's Weight Loss (dba. Waisted With Lucy) — Arlington, TX

FDA drug recall D-0881-2016 was initiated by Lucy's Weight Loss (dba. Waisted With Lucy) on September 23, 2015 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein. The recall status is terminated (terminated November 16, 2022). Affected quantity: N/A.

Recall Details

Product Type
Drugs
Report Date
June 1, 2016
Initiation Date
September 23, 2015
Termination Date
November 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Shorts on The Beach Golden Edition by Pink Bikini, 800 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.

Distribution Pattern

Nationwide

Code Information

All lots

Other recalls by Lucy's Weight Loss (dba. Waisted With Lucy)

  • D-0882-2016 Class I — Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottl (December 9, 2015)
  • D-0883-2016 Class I — Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-cou (December 9, 2015)
  • D-0880-2016 Class I — Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in (September 23, 2015)
  • D-0879-2016 Class I — Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle (September 23, 2015)

FDA data resources