FDA (Drugs) recall action 83427
The FDA (Drugs) publishes a recall like this one as 32 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 32 pages.
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
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.
Colonia Care Pharmacy is recalling specific vials of Calcium Gluconate 1% Injection because the sterility of the product cannot be guaranteed.
Colonia Care Pharmacy is recalling 7 vials of C-Urea 40% Bladder Instill because the product's sterility cannot be guaranteed.
Colonia Care Pharmacy is recalling C-Atropine Sulfate Ophthalmic Solution 0.02% because the product's sterility cannot be guaranteed.
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Colonia Care Pharmacy is recalling C-Phenol/Cottonseed Oil Injection 5% vials because the sterility of the product cannot be guaranteed.
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.