FDA Drug Recalls

Recalls / Class I

Class ID-1451-2020

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

Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76553 7

Affected lot / code info
FG003107

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
495 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-1451-2020. 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