Class II · Moderate risk
Sterile Water for Injection
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
FDA Drug Recalls
6 recalls · Class II, newest first
Class II · Moderate risk
Vitamin C (ascorbic acid)
Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
Class II · Moderate risk
Relumins Advanced Glutathione
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Class II · Moderate risk
Saluta (reduced glutathione)
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Class II · Moderate risk
Tatiomax (reduced glutathione/hydrolyzed collagen)
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk
Laroscorbine Platinium
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.