Recalls / Class I
Class ID-0894-2016
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
Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 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-0894-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.