Hospira recalls single Sodium Bicarbonate Injection lot
Hospira Inc., which operates as part of Pfizer, recently issued a voluntary recall for its Sodium Bicarbonate Injection, USP because of a particulate that has been found in a single-dose glass flip-top vial.
The company only needs to recall a single lot of the product, which has been isolated at the hospital and retail level. Hospira first became aware of the issue because of a confirmed complaint.
If health professionals do not catch the particulate before it is administered through IVs, the particulate will break into smaller particulates. These will then go into the catheter, potentially causing allergic reactions, localized inflammation, microembolic effects, anaphylaxis and granuloma formation.
If there are larger pieces of the particulate, these could block the solution from spreading throughout the body. This could cause a delay in therapy, resulting in serious health repercussions for patients.
The chances of this happening to the patient is extremely low. This is thanks to the particulate’s high detectability before or during the patient’s care; even though this is a serious concern, the chances of it causing harm is extremely low.
This is the first time that Hospira has learned of adverse experiences because of this lot of treatments. The company focuses on safety for patients and quality for products as its highest priorities -- throughout the production and supply process.
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U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903