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Companies / Zions RX Formulations Services LLC dba RX Formuations Serv.
Zions RX Formulations Services LLC dba RX Formuations Serv.
FDA Regulatory Profile
Summary
- Total Recalls
- 7 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1217-2014 | Class II | Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Ad | December 12, 2013 |
| D-1213-2014 | Class I | Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administra | December 12, 2013 |
| D-1219-2014 | Class II | Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration | December 12, 2013 |
| D-1214-2014 | Class II | Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administrati | December 12, 2013 |
| D-1215-2014 | Class II | Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx F | December 12, 2013 |
| D-1218-2014 | Class II | Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, | December 12, 2013 |
| D-1216-2014 | Class II | Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administratio | December 12, 2013 |