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Recall Observatory FDA recall evidence

Drug product

Dr. King's SafeCare Rx Upper GI Restoration Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive Asheville, NC 28806 USA, UPC 357955032120, NDC 57955-0325-2

D-0698-2019

July 20, 2018

Class I

Product summary

Firm
King Bio Inc.
Event
Event 80601
Status
Terminated
Classification
Class I
Quantity
756 bottles
Official record key
drug-enforcement:D-0698-2019

Official wording

Reason: Microbial contamination

Code information: Lots: 051716U Exp. 05/19; 073115C Exp. 07/18; 080216C Exp. 08/19; 120217N Exp. 12/19

Distribution pattern: U.S.A. Nationwide, Canada, and Australia.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination