FDA (Drugs) recall action 65019
The FDA (Drugs) publishes a recall like this one as 43 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 43 pages.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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.
Nora Apothecary is recalling Folic Acid Inj 5mg/ml due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Bimix Inj 30:1 syringes because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling 72 units of Trimix Penile Injection nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Meperidine 100mg/ml MDV, 5ml vials due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling PGE-1 penile injections nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. recalled HCG injection products because FDA inspection findings raised concerns about quality control and sterility assurance. The products were distributed nationwide.
Nora Apothecary is recalling HCG Inj 1250 un/ml MDV injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Lidocaine 2% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Vancomycin Ophthalmic Solution because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling 7 units of Dexamethasone Opth Soln 0.1% PF due to lack of assurance of sterility identified during an FDA inspection.
Nora Apothecary and Alternative Therapies, Inc. is recalling Papaverine Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Renacidin Irrigation bladder irrigation products due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Methylcobalamin 5mg/ml Injection Syringes due to FDA inspection findings regarding quality control and lack of assurance of sterility.