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BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) In...

FDA Recall #D-0292-2019 — Class II — November 16, 2018

Recall #D-0292-2019 Date: November 16, 2018 Classification: Class II Status: Terminated

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.

Recalling Firm

CAO Group, Inc. — West Jordan, UT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

803 units (400 kit and 403 30 ml bottles)

Distribution

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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