FDA Drug Recalls

Recalls / Class I

Class ID-0964-2019

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 Regional Allergies Eastern Canada, 59 mL, (liquid/liquide) DIN-HM 80075212 UPC 357955181620

Affected lot / code info
Lots: 060917E Exp. 06/20; 021517K Exp. 02/20

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
957 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-0964-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.