Home / Recalls / Zions RX Formulations Services LLC dba RX Formuations Serv. / D-1218-2014

D-1218-2014 Class II Terminated

Recalled by Zions RX Formulations Services LLC dba RX Formuations Serv. — Mesa, AZ

Recall Details

Product Type
Drugs
Report Date
April 16, 2014
Initiation Date
December 12, 2013
Termination Date
May 1, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
60 units

Product Description

Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

Reason for Recall

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.

Distribution Pattern

AZ

Code Information

Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013

Other recalls by Zions RX Formulations Services LLC dba RX Formuations Serv.

  • D-1217-2014 Class II — Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispens (December 12, 2013)
  • D-1213-2014 Class I — Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For (December 12, 2013)
  • D-1219-2014 Class II — Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hos (December 12, 2013)
  • D-1214-2014 Class II — Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For H (December 12, 2013)
  • D-1215-2014 Class II — Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Admin (December 12, 2013)
  • D-1216-2014 Class II — Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Ho (December 12, 2013)