Recalls / Class II
Class IIF-1497-2020
Product
"SUNDIAL***TRADITIONAL HERBAL FORMULA***Flu-Allergies HayFever***" packaged in boxes
- Type
- Food
- Affected lot / code info
- Product manufactured, processed, packed, held, and/or distributed during the time period beginning 1/1/2014 through 5/27/2020.
- Quantity
- Unknown
Why it was recalled
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Recalling firm
- Firm
- Sundial Herbal Products
- Notification channel
- Letter
- Type
- FDA Mandated
- Address
- 3609 Boston Rd, N/A, Bronx, New York 10466-5810
Distribution
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2020-06-30
- FDA classified
- 2020-09-15
- Posted by FDA
- 2020-09-09
- Terminated
- 2022-10-26
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1497-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings.