Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0062-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.
Reason: Lack of Assurance of Sterility
D-0052-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Reason: Lack of Assurance of Sterility
D-0055-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0084-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosom...
Reason: Lack of Assurance of Sterility
D-0081-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0071-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0040-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0059-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0079-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0048-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0049-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0072-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0077-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also la...
Reason: Lack of Assurance of Sterility
D-0065-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0067-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0060-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0066-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0061-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0050-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELI...
Reason: Lack of Assurance of Sterility
D-0086-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
D-0058-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.