FDA recall D-0292-2019

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

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2018-11-16

Report date

2018-12-19

Termination date

2020-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0292-2019