D-0296-2016 Class I Terminated
FDA drug recall D-0296-2016 was initiated by Blue Square Market, Inc. on August 6, 2015 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein. The recall status is terminated (terminated October 18, 2018). Affected quantity: 25 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- November 25, 2015
- Initiation Date
- August 6, 2015
- Termination Date
- October 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 boxes
Product Description
LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd
Reason for Recall
Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
Distribution Pattern
Nationwide
Code Information
all lots