FDA (Drugs) recall action 64957
The FDA (Drugs) publishes a recall like this one as 26 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 26 pages.
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Lack of Sterility Assurance
The agency’s own wording, quoted from the enforcement report.
Axium Healthcare Pharmacy is recalling BiMix Standard Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Quadmix Custom Injectable vials due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Mono-mix (Prostaglandin) Injectable due to lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Cyanocobalamin (CMP) Injectable vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Methylcobalamin and Folic Acid Injectables because the products may lack sterility assurance.
Axium Healthcare Pharmacy is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable vials due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling QuadMix Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Betamethasone Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling all lots of Cyclosporin in Corn Oil Injectable due to lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling BiMix Plus Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Comprehensive Injection #4 because the compounding process lacked assurance of sterility. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
Axium Healthcare Pharmacy is recalling 172 vials of Triamcinolone Diacetate Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate for Injectable due to lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
Axium Healthcare Pharmacy is recalling all lots of Progesterone in Olive Oil Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Methylprednisolone Acetate injectable vials due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Triamcinolone Acetonide Injectable due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Cyclosporin (Grapeseed Oil) Ophthalmic vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Phosphatidylcholine Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling BiMix Customs Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling all lots of Bacteriostatic Water for Injection 0.9% due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling TriMix Injectable vials due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Trimix injectable vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide Injectable vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate Injectable due to lack of sterility assurance and quality control concerns.