FDA Drug Recalls

Recalls / Class I

Class ID-0554-2019

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

Dr. King's Natural Medicine Homeopathic Appetite & Weight with P.H.A.T., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955515623, NDC 57955-5181-2

Affected lot / code info
Lot Numbers: 021718D Exp. 02/20; 112317C Exp. 11/19; 012616G Exp. 01/19; 033116A Exp. 03/19; 052517F Exp. 05/20; 072916D Exp. 07/19; 091415H Exp. 09/18; 091616A Exp. 09/19; 121916C Exp. 12/19

Why it was recalled

Microbial contamination

Recalling firm

Firm
King Bio Inc.
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
3 Westside Dr, N/A, Asheville, North Carolina 28806-2846

Distribution

Quantity
26410 bottles
Distribution pattern
U.S.A. Nationwide, Canada, and Australia.

Timeline

Recall initiated
2018-07-20
FDA classified
2019-03-08
Posted by FDA
2019-03-20
Terminated
2022-01-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0554-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.