Late August has been rough for IV solution makers as B. Braun added to its recall tally once more, building on Baxter’s three recalls of similar products in the same time frame.
The latest recall update by B. Braun—which also said it was pulling several IV solutions batches on Aug. 19 due to the presence of particulate matter—covers three lots of 0.9% sodium chloride injection.
The product pull was initiated after a foreign substance, identified as iron oxide, was found in the product, and B. Braun said it has updated its notice to reflect that.
Sodium chloride is typically used for adults and children to provide electrolytes and water for hydration. The recalled product is packaged in a non-PVC, non-DEHP flexible container system and was distributed across the U.S. between February and early August this year. The specific lots involved are J6B435, J6B444 and J6B45, the company said in a notification posted to the FDA website.
Using the recalled solution carries a “reasonable probability” of blocking pulmonary blood vessels, occluding other blood vessels—which can lead to tissue death and possible organ damage—or causing inflammation of the walls of veins, which can cause clotting, the company warned.
As of Aug. 19, B. Braun had not received any adverse event reports tied to the latest recall.
That same day, B. Braun announced that it was pulling one lot each of 0.9% sodium chloride injection and lactated ringers injection—a source of water and electrolytes for patients in need of hydration and fluid replacement—due to the presence of unidentified particulate matter in the drugs' containers.
B. Braun also revealed this month the recall of a lactated ringer's lot with a separate batch number, which it had flagged due to the potential presence of cellulose cotton fiber, among other particles.
B. Braun’s recall comes amid a string of three such actions by Baxter in the same week. Baxter’s third recall covered two lots of 0.9% sodium chloride injection because of the potential presence of fiberglass in the solution.
Baxter had previously recalled one lot of anticoagulant sodium citrate after fiberglass was detected in the solution, and one lot of Dextrose Injection because of the potential presence of stainless steel particles.