Drug 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
D-0292-2019
Product summary
- Firm
- CAO Group, Inc.
- Event
- Event 81556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 803 units (400 kit and 403 30 ml bottles)
- Official record key
drug-enforcement:D-0292-2019
Official wording
Reason: cGMP violations noted during the firm's most recent inspection.
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
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
cGMP violations