FDA Drug Recalls

Recalls / Class I

Class ID-0982-2019

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 Leg Cramp & Spasm Relief Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955543527, NDC 57955-6035-2

Affected lot / code info
Lots: 102816D Exp. 10/19; 050516F Exp. 05/19; 101416A Exp. 10/19; 123115D Exp. 12/18; 041518J Exp. 04/20

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
9405 bags
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-0982-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.