Baxter International Inc. just issued a recall of certain lots of two of its injectable products due to particulate matter found in the 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 into the body that contains particulate matter may lead to blockages of blood vessels. These blockages may lead to stroke; heart attack; or organ damage, such as to the liver or kidneys. Potential allergic reactions, local irritation, and tissue and organ inflammation are also possible reactions. The cause of the problem that led to this recall has been identified and resolved.
Both recalled products are delivered by intravenous injection. Dextrose Injection, USP is used as a source of water and calories. Sodium Chloride Injection, USP is used as a source of water and electrolytes, as well as a priming solution in hemodialysis procedures. Both the 50 mL and 100 mL containers are generally used for admixture of medication, as well as priming solutions.
The recalled products were packaged in flexible plastic containers with 96 products 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 advised its customers not to use, or to stop using, the recalled dextrose and sodium chloride injections and arrange for their return for credit. The recalled products 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).
Meanwhile, Baxter International Inc. also recently recalled two lots of its Dual Luer Lock Caps, also over the presence of loose particulate matter that was detected in the packaging. The FDA deemed that recall a Class I. A Class I recall involves a situation in which there is 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 body’s fluid path from the Luer Lock Caps may result in serious thrombotic and embolic events, including pulmonary embolism, myocardial infarction, and stroke.