So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.
While neither recall has resulted in any safety flags or side effect reports so far, the issues stemming from the faulty products could be severe, the drugmakers have warned.
First up, German drug and devicemaker B. Braun Medical is yanking two lots of injectable 0.9% sodium chloride to the consumer level in the U.S. The company blamed the product pull on the potential for particulate matter and fluid leakage from the product’s “E3 containers.”
The solution is used in both kids and adults as a source of electrolytes and water for hydration. The product is specifically approved for extracellular fluid replacement, treatment of metabolic alkalosis with fluid loss and mild sodium depletion. The product is also used as a priming solution for hemodialysis procedures and may be used to kick-start and terminate blood transfusions without hemolyzing red blood cells.
The German firm says it mistakenly released the affected batches to domestic distributors across the U.S. before completing required acceptance activities for embedded particulate matter.
While the company hadn’t received any safety reports as of Aug. 8, there is a risk of patients suffering embolic issues like stroke or ischemia/infarction to other organs, plus possible infection, if the particulates in the product aren’t sterile, B. Braun warned.
Separately, Baxter International is voluntarily withdrawing a single lot of heparin sodium in 0.9% sodium chloride injection due to the potential for elevated endotoxin levels.
The injection is used as an anticoagulant to maintain catheter patency—or the state of being open or unobstructed. Baxter says it shipped the suspect batch to U.S. healthcare facilities, wholesalers and distributors between March 12 and Aug. 24.
Using heparin with excess endotoxin levels could lead to serious health consequences for patients such as toxic shock, organ failure and death, the company warned.
As of Aug. 6, the company hadn’t received any adverse event reports tied to the product pull.
Over the last year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more.
Most recently, Endo USA—a unit of Endo Pharmaceuticals—recalled a single lot of clonazepam tablets in July thanks to a labeling issue that resulted in an incorrect strength being printed on the product cartons.
Endo blamed the issue on a third-party packager.
As for the risk of particulate matter turning up in drugs, Pfizer’s Hospira in October recalled three lots of sodium bicarbonate and lidocaine HCI injectables due to the possible presence of glass particles in vials.