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Recall Observatory FDA recall evidence

Drug product

LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd

D-0296-2016

August 06, 2015

Class I

Product summary

Firm
Blue Square Market, Inc.
Event
Event 71912
Status
Terminated
Classification
Class I
Quantity
25 boxes
Official record key
drug-enforcement:D-0296-2016

Official wording

Reason: Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.

Code information: all lots

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.