FDA (Drugs) recall action 65360
The FDA (Drugs) publishes a recall like this one as 105 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 105 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.
Olympia Pharmacy is recalling Aminophylline 2.5% Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
Olympia Pharmacy is recalling Diclazuril 10 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Metabolase Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Oxytocin 20 units/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Betamethasone Phosphate/Acetate 6 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling HACC 270.1 Injection because FDA inspection findings raised concerns about quality control processes and the assurance of sterility.
Olympia Pharmacy is recalling ITPP 50 mg/ml DMG 100 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling two lots of Gentamicin 300 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.
Olympia Pharmacy is recalling compounded Glutathione 200 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Cal-Phos 1000 Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Vitamin 15 (HEMO15) Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling PEN-DEX-CHLOR Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
Olympia Pharmacy is recalling Detomidine w/Xylazine Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Olympia Pharmacy is recalling compounded Gaba injections due to FDA inspection findings regarding quality control and sterility assurance.
Olympia Pharmacy is recalling Fluphenazine 25 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.
Olympia Pharmacy is recalling three lots of Quadmix because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Calcium Gluconate 23% because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Clenbuterol 0.03mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling compounded methylprednisolone acetate 80 mg/mL injection, code A3104, expiring June 4, 2013, because FDA inspection findings raised concerns about quality control and sterility assurance. The product was distributed nationwide and in Puerto Rico.
Olympia Pharmacy is recalling Cre-O-Pan Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
Olympia Pharmacy is recalling Naproxen 100 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Olympia Pharmacy is recalling two lots of compounded Chlorpromazine HCL 100 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Olympia Pharmacy is recalling Ketoprofen Solution 10% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling three vials of compounded Pentosan 250 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling one unit of compounded BNP/dexamethasone eye ointment because FDA inspection findings raised concerns about sterility assurance and quality control. The listed distribution is nationwide and Puerto Rico.