FDA Drug Recalls

Recalls / Class I

Class ID-1454-2020

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

A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Road Suite 1, Saginaw, MI 48603

Affected lot / code info
FG003106

Why it was recalled

Chemical contamination: product contains elevated levels of undeclared lead.

Recalling firm

Firm
MICHIGAN HERBAL REMEDIES
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
904 Chicago Dr, Jenison, Michigan 49428-9351

Distribution

Quantity
350 bottles
Distribution pattern
Nationwide via internet sales,retailers and distributors in the USA

Timeline

Recall initiated
2020-06-18
FDA classified
2020-08-04
Posted by FDA
2020-08-12
Status
Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-1454-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class I recall: drug · FDA Drug Recalls