Class II · Moderate risk
L-Arginine HCl for Injection
Lack of Assurance of Sterility
grande X 5800 capsule
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
Drug: Arginine
- Recalling firm
- Gadget Island, Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0106-2018 · 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 Arginine recalls
See all
Class II · Moderate risk
L-Arginine for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Lack of assurance of sterility.
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Other recalls by Gadget Island, Inc
All 2017 recalls
Class I · High risk
DYNAMITE SUPER capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
NUX Male Enhancement capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Pro Power Knight Plus capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
FIFTY SHADES 6000 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
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