Recalls / Class I
Class ID-0893-2016
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
African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
- Affected lot / code info
- all lots
Why it was recalled
Marketed Without An Approved NDA/ANDA
Recalling firm
- Firm
- R Thomas Marketing, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3704 White Plains Rd, N/A, Bronx, New York 10467-5710
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide via Internet sales
Timeline
- Recall initiated
- 2016-01-09
- FDA classified
- 2016-05-26
- Posted by FDA
- 2016-06-01
- Terminated
- 2019-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0893-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.