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 Pentosan for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling CoQ10 for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling NAD+ for Injection at 100 mg/mL and 200 mg/mL from one lot for microbial contamination of sterile products, with elevated endotoxin levels.
GenoGenix is recalling Zinc Chloride for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling preserved Ascorbic Acid (Vitamin C) for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.
GenoGenix is recalling combined BPC-157/Thymosin Beta-4 for Injection across three lots for lack of assurance of sterility.
GenoGenix is recalling Ultra Burn for Injection in all strengths and presentations, covering all lots within expiry, for lack of assurance of sterility.