Product: Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 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.
Recall initiated: 20131212
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated