Home / Recalls / Bee Extremely Amazed LLC / D-1150-2016

D-1150-2016 Class I Terminated

Recalled by Bee Extremely Amazed LLC — Jewett, OH

Recall Details

Product Type
Drugs
Report Date
July 13, 2016
Initiation Date
December 15, 2015
Termination Date
April 23, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health

Reason for Recall

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Distribution Pattern

Nationwide

Code Information

All lots

Other recalls by Bee Extremely Amazed LLC

  • D-1138-2016 Class I — Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.as (December 15, 2015)
  • D-1148-2016 Class I — Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tan (December 15, 2015)
  • D-1141-2016 Class I — Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition (December 15, 2015)
  • D-1145-2016 Class I — Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. # (December 15, 2015)
  • D-1140-2016 Class I — EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. At (December 15, 2015)
  • D-1142-2016 Class I — Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions (December 15, 2015)
  • D-1147-2016 Class I — SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition (December 15, 2015)
  • D-1143-2016 Class I — La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Health (December 15, 2015)
  • D-1149-2016 Class I — XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health (December 15, 2015)
  • D-1146-2016 Class I — SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceutic (December 15, 2015)