D-0292-2019 Class II Terminated
FDA drug recall D-0292-2019 was initiated by CAO Group, Inc. on November 16, 2018 and is designated Class II. Reason for recall: cGMP violations noted during the firm's most recent inspection. The recall status is terminated (terminated February 27, 2020). Affected quantity: 803 units (400 kit and 403 30 ml bottles).
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