Home / Recalls / CAO Group, Inc. / D-0292-2019

D-0292-2019 Class II Terminated

Recalled by CAO Group, Inc. — West Jordan, UT

Recall Details

Product Type
Drugs
Report Date
December 19, 2018
Initiation Date
November 16, 2018
Termination Date
February 27, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
803 units (400 kit and 403 30 ml bottles)

Product Description

BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084

Reason for Recall

cGMP violations noted during the firm's most recent inspection.

Distribution Pattern

Nationwide in the US

Code Information

Lots #: a) 110216, EXP 11/02/18; 170524, EXP 5/24/2019; 171116, EXP 11/16/2019; 180319, EXP 3/19/2020; b)110216, EXP 11/02/2018; 170323, EXP 3/23/2019; 180109, EXP 1/09/2020

Other recalls by CAO Group, Inc.

  • D-0290-2019 Class II — fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc P (November 16, 2018)
  • D-0293-2019 Class II — FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3 (November 16, 2018)
  • D-0291-2019 Class II — SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. (November 16, 2018)