Class I · High risk
Zhen Gong Fu
Marketed Without An Approved NDA/ANDA
Bigger Longer More Time More Sperms
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without An Approved NDA/ANDA
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
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
- Recalling firm
- R Thomas Marketing, LLC
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0894-2016 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by R Thomas Marketing, LLC
All 2016 recalls
Class I · High risk
Super Hard
Marketed Without An Approved NDA/ANDA
Class I · High risk
Samurai-X
Marketed Without An Approved NDA/ANDA
Class I · High risk
Tiger King
Marketed Without An Approved NDA/ANDA
Other unapproved drug recalls from 2016
All unapproved drug recalls
Class I · High risk
Domperidone capsules 10 mg
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Class II · Moderate risk
Zinc Acetate
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class II · Moderate risk
Oxygen Nasal Wash
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Class II · Moderate risk
Fuqingsong Relief Cream
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
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