Sodium Chloride Injection Recalled Due to Particulate Matter

Baxter International is voluntarily recalling 2 lots of its 0.9% sodium chloride injection due to complaints of particle matter, according to the FDA.

The recall was initiated after a vial adapter fragment was identified in the solution prior to patient administration in 2 separate incidents.

The affected lots of Baxter’s 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container are lot numbers P317842 and P317891. Unaffected lot numbers can continue to be used in accordance with the product’s instructions.

Baxter has notified customers of the recall and directed them not to use products from the affected lots. Recalled products should be returned to Baxter for credit by contacting Baxter at 1-888-229-0001, and unaffected lots are available for replacement. Consumers with questions regarding this recall can contact Baxter by phone at 1-800-422-9837 or e-mail at onebaxter@baxter.com.

In addition to contacting their health care provider, patients who have experienced adverse reactions to this product should report them to the FDA's MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.