FDA recall D-1217-2014

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.

Distribution

AZ

Key facts

Status

Terminated

Initiation date

2013-12-12

Report date

2014-04-16

Termination date

2014-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mesa, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1217-2014