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Recall Observatory FDA recall evidence

Drug product

Dr. King's Natural Medicine Homeopathic Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955503927, NDC 57955-5839-2

D-0598-2019

July 20, 2018

Class I

Product summary

Firm
King Bio Inc.
Event
Event 80601
Status
Terminated
Classification
Class I
Quantity
18449 bottles
Official record key
drug-enforcement:D-0598-2019

Official wording

Reason: Microbial contamination

Code information: Lots: 021016E Exp. 02/19; 060118C Exp. 06/20; 060518A Exp. 06/20; 071318G Exp. 07/20; 080717A Exp. 08/19; 081315N Exp. 08/18; 111516J Exp. 11/19; 122017A Exp. 12/2019; 122915D Exp. 12/18

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination