FDA (Drugs) recall action 67080
The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.
Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
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.
Zions RX Formulations is recalling 450 vials of Calcium Gluconate 10% for Injection due to a report of microbial contamination.
Zions RX Formulations is recalling 861 bags of Magnesium Sulfate in Lactated Ringers due to poor aseptic practices that compromise sterility assurance.
Zions RX Formulations is recalling 1,495 bags of Oxytocin 30 Units in 500mL Sodium Chloride 0.9% due to a lack of assurance of sterility.
Zions RX Formulations is recalling 95 vials of Potassium Phosphates due to a lack of assurance of sterility caused by poor aseptic practices.
Zions RX Formulations is recalling 610 units of Sodium Bicarbonate 8.4% injectable products due to a lack of assurance of sterility.
Zions RX Formulations Services LLC is recalling specific lots of Vitamin B-12 injections due to a lack of assurance of sterility resulting from poor aseptic practices.
Zions RX Formulations is recalling 60 units of Bupivacaine 3% in Arizona due to poor aseptic practices that compromised sterility assurance.