FDA Recall D-0902-2019

King Bio Inc. · Asheville, NC

Class I — life-threatening Terminated 1279 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Aquaflora Phase I Candida Control Program, Net 16 fl. oz. (1 PT) 473 mL, Homeopathic Formula, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955160168, NDC 57955-1601-6

Lot / code: Lots: 022218D Exp. 02/20; 100917D Exp. 10/19; 021717A Exp. 02/20; 041816B Exp. 04/19; 062816F Exp. 06/19; 122815B Exp. 12/18

Quantity: 6153 bottles

Reason for recall

Microbial contamination

Recall record

Recall number: D-0902-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: U.S.A. Nationwide, Canada, and Australia.
Recall initiated: 2018-07-20
Classified by FDA Center: 2019-03-08
FDA published: 2019-03-20
Terminated: 2022-01-19
Recalling firm: King Bio Inc.
Firm location: Asheville, NC

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