Baxter announced a voluntary recall of two lots of 0.9% Sodium Chloride intravenous (IV) solutions due to potential particulate matter. The particulate in each case was confirmed to be an insect following a customer complaint.
The affected products are: 0.9% Sodium Chloride Injection, 50mL VIAFLEX plastic container, with Lot #P319921 and 12/31/15 expiration date; and 0.9% Sodium Chloride Injection, 100mL, MINI-BAG plus container, with Lot #P327635 and 12/30/15 expiration date. The recalled lots were distributed between October 7, 2014 and July 14, 2015. The solutions are indicated for use as a source of water and electrolytes; the 100mL MINI-BAG plus container can also be used as a diluent for reconstitution of some powdered drug products.
Administering an injectable containing particulate matter without in-line filtration can result in blockage of blood vessels. This can lead to stroke, heart attack or other organ damage. Allergic reactions, local irritation and inflammation in tissues and organs could also possibly occur.
For more information call (800) 229-0001 visit FDA.gov.