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Hospira Inc, a Pfizer company, is voluntarily recalling 1 lot of 8.4% sodium bicarbonate injection due to the potential presence of particulate matter.
Hospira Inc, a Pfizer company, is voluntarily recalling 1 lot of 8.4% sodium bicarbonate injection due to the potential presence of particulate matter.
The recall, which was issued after a confirmed complaint, affects lot 56-148-EV, which has an expiration date of August 1, 2017.
The particulate may be found within the single-dose glass fliptop vial.
In the event that the contamination is not recognized beforehand, the particulate matter could break off into smaller pieces during IV administration. It may pass through a catheter and result in an allergic reaction and inflammation.
Hospira has not received any news of adverse effects stemming from the potential contamination. The company continues to encourage individuals to stop using the product immediately and report any effects to the FDA’s MedWatch Adverse Event Reporting program.
The affected products were distributed across the United States in December 2015.
Hospira is still working to determinine the root cause of the contamination, as well as what can be done to prevent it from happening in the future.