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 and Alternative Therapies, Inc. is recalling Pyridoxine 100mg/ml Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling PGE-1 Penile Injections because FDA inspections raised concerns about quality control and the assurance of sterility.
Nora Apothecary is recalling Chlorhexidine Ophthalmic Solution 0.02% because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Super Trimix #1 Penile Injection because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Bimix Inj 30:1 syringes 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 PGE-1 Penile Injections because FDA inspections raised concerns about quality control and sterility assurance.
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. 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 PGE-1 Penile Injections because FDA inspections raised concerns about quality control and assurance of sterility.
Nora Apothecary and Alternative Therapies, Inc. is recalling Bimix Inj 30:0.5 MDV Penile Injection 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 is recalling Vancomycin Ophthalmic Solution 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 Bimix Inj 30:1 MDV penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Lidocaine 2% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 Glutathione 200mg/ml injections nationwide due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
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 Papaverine Injections due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Nora Apothecary is recalling Tobramycin Ophthalmic Solution because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and the assurance of sterility.