FDA (Drugs) recall action 85217
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
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.
Medical Center Pharmacy is recalling Vancomycin Opthal 14 mg drops because production processes could not assure sterility. The product was distributed to patients in Tennessee.
Medical Center Pharmacy is recalling 250 mL bags of Gentamicin/Bacitracin Bladder Irrigation due to concerns that production processes cannot assure sterility.
Medical Center Pharmacy is recalling two bottles of Mitomycin 0.04% Ophth DR eye drops because production processes could not assure sterility.
Medical Center Pharmacy is recalling specific lots of C-Albumin Eye Drop 10% S because production processes cannot assure sterility. Patients in Tennessee who received these prescriptions should contact their healthcare provider.
Medical Center Pharmacy is recalling Morphine 2 mg/mL CADD Cassettes because production processes cannot assure sterility. Patients in Tennessee who received specific prescriptions should contact their healthcare provider.