Recalls / Class I
Class ID-1460-2020
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
Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99271 0
- Affected lot / code info
- FG003236
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
- 50 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-1460-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.