FDA Recall D-0901-2019

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 II 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 357955160267, NDC 57955-1602-6

Lot / code: Lots: 010518G Exp. 07/18; 011617F Exp. 01/20; 021016G Exp. 02/19; 051716P Exp. 02/19; 072315A Exp. 07/18

Quantity: 2248 bottles

Reason for recall

Microbial contamination

Recall record

Recall number: D-0901-2019
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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