Drug Safety Alerts

8.4% Sodium Bicarbonate Injection 50mEq (1mEq/mL) 50 mL single-dose vial Class I Recall

06/01/2016


On June 1, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding Class I Recall of 8.4% Sodium Bicarbonate Injection 50mEq (1mEq/mL) 50 mL single-dose vial manufactured by Hospira Inc. This recall was issued due to presence of particulate matter identified as an insect in one vial. If the particulate is not observed prior to IV administration and breaks off into smaller particulates, passing through the catheter, it may result in localized inflammation, allergic reaction, including anaphylaxis, granuloma formation or microembolic effects (IV only). Larger particulates may block the infusion of solution, potentially resulting in a delay in therapy. The likelihood of risk to the patient is low due to the high detectability of the particulate prior to or at the point of care.

This recall affects lot number56-148-EV exp. 08/01/17. The lot went into distribution December 2015.

This recall was originally issued to the hospital/retail-level on March 21, 2016. The FDA classified this recall as a Class I Recall on June 1, 2016.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using 8.4% Sodium Bicarbonate Injection 50mEq (1mEq/mL) 50 mL single-dose vial to contact their prescriber.

For more information about this recall, health care providers may contact Hospira Customer Service toll-free at 1-877-946-7747. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.