Baxter International Inc. has recalled specific lots of its injectable products over particulate matter found in the products’ solutions, the U.S. Food and Drug Administration (FDA) announced.
The recall involves one lot of 5 percent Dextrose Injection, USP and four lots of 0.9 percent Sodium Chloride Injection, USP.
Injecting a product that contains particulate matter into the body may cause blockages of blood vessels, which may lead to stroke; heart attack; or other organ damage, such as to the kidneys or liver. There is also the potential for allergic reactions, local irritation, and tissue and organ inflammation. The root cause of the problem has been identified and resolved.
Both products are intravenous injectable products. Dextrose Injection, USP, as indicated, is used as a source of water and calories, while Sodium Chloride Injection, USP, as indicated, is used as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. Both the 50 mL and 100 mL containers are typically used for admixture of medication and as priming solutions.
The recalled products were packaged in flexible plastic containers with 96 units per carton and were distributed to healthcare centers and distributors in Saudi Arabia, Singapore, United Arab Emirates, the United States, and Puerto Rico. The recalled Baxter International products are:
- 5% Dextrose Injection, USP: Product Code 2B0089, NDC 0338-0017-38, Container 100 mL, Lot Number P285288, Expiration Nov-13.
- 0.9% Sodium Chloride Injection, USP: Product Code 2B1308, NDC 0338-0049-31, Container 50 mL, Lot Number P297283, Expiration Aug-14.
- 0.9% Sodium Chloride Injection, USP: Product Code 2B1302, NDC 0338-0049-18, Container Size 100 mL, Expiration Apr-14 and Lot Number P293993 and Expiration May-14.
- 0.9% Sodium Chloride Injection, USP: Product Code 2B1309, NDC 0338-0049-38, Container Size 100 mL, Lot Number P293514, Expiration Apr-14.
Baxter notified customers to not use, or to stop using, the recalled dextrose and sodium chloride injections and arrange for their return for credit; the affected lots were distributed between May 2012 and October 2013. Baxter Healthcare Center for Service may be reached, toll-free, at 1.888.229.0001, Monday through Friday, between 7:00 a.m. and 6:00 p.m., Central Time (CT).
Recently, Baxter International Inc. recalled two lots of its Dual Luer Lock Caps, also over the presence of loose particulate matter detected in the packaging. The FDA deemed that recall a Class I, which means that the recall involved a situation in which there was a reasonable probability that the use of, or exposure to, the recalled product—in that case, the recalled Dual Luer Lock Caps—may cause serious adverse health consequences or death. Particulate matter entering the fluid path from the Luer Lock Caps may result in serious thrombotic and embolic events, including pulmonary embolism, myocardial infarction, and stroke.