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 Miconazole 3% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Beta Alanine and L-Carnosine injections because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Buprenorphine 0.3 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Adenosine-Mono-Phosphate Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Furosemide 50 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Atipamezole 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Voriconazole 5% Ophthalmic drops because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Iodine 20 mg Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Idoxuridine 0.1% Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Gentamicin 80 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Taurine 100 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
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 Clenbuterol 0.03mg/ml Injection because FDA inspection findings 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 Vitamin A/D3/E Olive Oil 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 Metabolase Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling two lots of Hippiron 20 mg/ml Injection because FDA inspections 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 Phenylephrine 1 mg/ml Injection because FDA inspections 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 MICC and MICC 25/50/330 injections because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Dexpanthenol 250 mg/ml Injection due to FDA inspection findings regarding 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 Ceftiofur GM vials because FDA inspection findings raised concerns about quality control and sterility assurance.