FDAClass IIDecember 19, 2018

BeeGentle Honey Flavored Topical Anesthetic recall: CGMP Deviations

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

Why was BeeGentle Honey Flavored Topical Anesthetic recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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
Recalling firm
CAO Group, Inc.
Quantity
803 units (400 kit and 403 30 ml bottles)
Distribution
Nationwide in the US
Recall date
December 19, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls