FDA (Drugs) recall action 97369
The FDA (Drugs) publishes a recall like this one as 57 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 57 pages.
Lack of Assurance of Sterility
Microbial Contamination of Sterile Products: elevated endotoxin levels
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GenoGenix is recalling Biotin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling B12 Hydroxocobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling NAD+ injection at 50 mg/mL and 100 mg/mL in 10 mL multi-dose vials, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Cerebrolysin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Sermorelin lyophilized powder for reconstitution, 10mg in a 10 mL multi-dose vial, from a single lot for lack of assurance of sterility.
GenoGenix is recalling B6 (Pyridoxine HCl) for Injections in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling L-Carnitine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Thymosin Beta-4 (TB4) for Injection, 15mg, in all presentations from a single lot for lack of assurance of sterility.
GenoGenix is recalling L-Arginine HCl for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Oxytocin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Semaglutide for Injection, 20 mg in 10 mL multi-dose vials, from two lots for lack of assurance of sterility.
GenoGenix is recalling Low Solubility Peptide Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling GHK-Cu (Copper Peptide) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Lysine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Glycine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Elite Stack MSC Exosome Reconstitution Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Proline for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Magnesium Chloride for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Semaglutide with B12 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Vitamin D3 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Lipo MIC + B12 Methylcobalamin for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Bacteriostatic Water for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Glutathione Magnesium for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Lipo MIC + L-Carnitine for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling Reconstitution XO Solution for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.