Glycine 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-0054-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Methylene Blue 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-0063-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
GHK-Cu (Copper Peptide) 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-0051-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.
Reason: Lack of Assurance of Sterility
D-0047-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Vitamin D3 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-0069-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Glutathione Preserved 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-0053-2026October 15, 2025Boca Raton, FL
RC Outsourcing, LLC
Class IITerminated
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
Reason: Lack of assurance of sterility.
D-0003-2026October 15, 2025Lowellville, OH
GenoGenix LLC
Class IIOngoing
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10m...
Reason: Lack of Assurance of Sterility
D-0085-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10...
Reason: Lack of Assurance of Sterility
D-0091-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Amino Blend 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-0039-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Pentosan 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-0078-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Semaglutide with B12 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-0083-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Bacteriostatic Water 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, Extension Health ...
Reason: Lack of Assurance of Sterility
D-0046-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
pH Buffered Reconstitution 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 Medical Health I...
Reason: Lack of Assurance of Sterility
D-0080-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Sterile Saline Reconstitution Solution 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-0082-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Elite Stack MSC Exosome Reconstitution 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 Exte...
Reason: Lack of Assurance of Sterility
D-0074-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
L-Arginine HCl 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-0056-2026October 15, 2025Boca Raton, FL
GenoGenix LLC
Class IIOngoing
Elite Stack Reconstitution 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 Extension Health...