FDA (Drugs) recall action 64716
The FDA (Drugs) publishes a recall like this one as 25 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 25 pages.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
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.
Pallimed Solutions is recalling Methylcobalamin PF vials nationwide due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling Atropine Injection compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling 862 vials of Trimix Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling Quadmix Injection vials because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Pallimed Solutions is recalling Acetylcysteine Ophthalmic Solution due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling Testosterone Cypionate/Propionate Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling Nandrolone Decanoate Injectable vials because FDA inspectional findings raised concerns about sterility assurance and quality control.
Pallimed Solutions is recalling Dexamethasone PF compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling Testosterone Cypionate/Enanthate injections nationwide due to FDA inspectional findings regarding sterility assurance and quality control.
Pallimed Solutions is recalling Vancomycin Ophthalmic PF due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling Bacteriostatic Water for Injection because FDA inspections found quality control issues that impacted sterility assurance.
Pallimed Solutions is recalling 261 vials of compounded HCG Chorionic Gonadotropin nationwide due to FDA inspectional findings regarding sterility assurance.
Pallimed Solutions is recalling Gentamicin Sulfate Irrigation nationwide because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling 71 vials of Buprenorphine HCl Veterinary Injection nationwide due to FDA inspectional findings regarding sterility assurance.
Pallimed Solutions is recalling compounded Cyclosporine Ophthalmic because FDA inspections raised concerns about quality control and sterility assurance.
Pallimed Solutions is recalling Tacrolimus Ophthalmic nationwide due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling Diazepam Injectable vials because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling MIC with B6 and B12 vials because FDA inspectional findings raised concerns about quality control procedures and sterility assurance.
Pallimed Solutions is recalling compounded Hydroxyprogesterone CAPR. (G.S.) due to FDA inspectional findings regarding quality control and sterility assurance.
Pallimed Solutions is recalling 597 vials of compounded Testosterone Cypionate Injection nationwide due to FDA inspectional findings regarding sterility assurance.
Pallimed Solutions is recalling DMSO Aqueous Irrigation 50% because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Pallimed Solutions is recalling 408 vials of Alprostadil IN NS Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.
Pallimed Solutions is recalling 246 vials of BiMix Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.
Pallimed Solutions is recalling 23 vials of compounded Cidofovir Ophthalmic Solution nationwide due to FDA inspectional findings regarding sterility assurance.
FDA is recalling Verapamil Injection compounded by Pallimed Solutions Pharmacy because inspectional findings raised concerns about quality-control procedures and sterility assurance. The recall covers all lots within expiry distributed nationwide.