Zions RX Formulations Services LLC dba RX Formuations Serv. recalls
FDA enforcement reports naming Zions RX Formulations Services LLC dba RX Formuations Serv. as the recalling firm.
- Recall reports
- 7
- Class I (serious)
- 1
- Most recent report
- Apr 16, 2014
- Apr 16, 2014Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospit…Drug · Zions RX Formulations Services LLC dba RX Formuations Serv.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.Class I
- Apr 16, 2014Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital…Drug · Zions RX Formulations Services LLC dba RX Formuations Serv.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.Class II
- Apr 16, 2014Potassium Phosphates 4Drug · Zions RX Formulations Services LLC dba RX Formuations Serv.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.Class II
- Apr 16, 2014Oxytocin 30 Units in 500mL Sodium Chloride 0Drug · Zions RX Formulations Services LLC dba RX Formuations Serv.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.Class II
- Apr 16, 2014Sodium Bicarbonate 8Drug · Zions RX Formulations Services LLC dba RX Formuations Serv.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.Class II
- Apr 16, 2014Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx…Drug · Zions RX Formulations Services LLC dba RX Formuations Serv.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.Class II
- Apr 16, 2014Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital A…Drug · Zions RX Formulations Services LLC dba RX Formuations Serv.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.Class II