Recalls / Class I
Class ID-1463-2020
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
Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Dist by: Javan Wellness LLC, 1445 Church St NW Unit 24, Washington, DC 20005
- Affected lot / code info
- FG003283
Why it was recalled
Chemical contamination: product contains elevated levels of undeclared lead.
Recalling firm
- Firm
- MICHIGAN HERBAL REMEDIES
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 904 Chicago Dr, Jenison, Michigan 49428-9351
Distribution
- Quantity
- 100 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-1463-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.