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 Gentamicin 0.3% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 specific lots of compounded Sodium Tetradecyl Sulfate injections due to FDA inspection findings regarding quality control and sterility assurance.
Olympia Pharmacy is recalling Betamethasone Sodium Phosphate 12 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Miconazole 3% 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 MICC and MICC 25/50/330 injections because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Vitamin B-Buildup Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Phenobarbital 62.5 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Sermorelin/GHRP vials because FDA inspection findings raised concerns about quality control processes and assurance of sterility.
Olympia Pharmacy is recalling Idoxuridine 0.1% Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Aminocaproic Acid 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Olympia Pharmacy is recalling Testosterone Cypionate injections 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 Phenylephrine 1 mg/ml Injection 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.
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 Yohimbine 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.
Olympia Pharmacy is recalling Medetomidine 2 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Caco/Copper 6.2 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Ketamine 100 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling two lots of Detomidine 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.
Olympia Pharmacy is recalling Pento-Gluc 200 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Olympia Pharmacy is recalling Gentamicin Sulfate 80 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.
Olympia Pharmacy is recalling compounded Vitamin B12 injections because FDA inspections raised concerns about quality control and sterility assurance.