Fresenius Kabi USA voluntarily recalled 163 lots of sodium chloride injections last week, noting that the product contains latex despite an insert that states otherwise.
The company’s recall includes 0.9% injections in 10 mL vials and 20 mL vials. The product insert and the tray label for both kinds of vials say that the products’ stoppers do not contain natural rubber latex. Fresenius Kabi notified distributors and customers by letter, telling them that the stoppers do contain natural rubber latex.
The company noted that it has not received any reports of adverse events related to the recall.
Fresenius Kabi’s 0.9% sodium chloride injection is designed for diluting or dissolving drugs for intramuscular, subcutaneous or intravenous injection. It can also be used to flush intravenous catheters.
The company wrote in a statement, published by the FDA, that it is working to arrange for the return of the recalled product.
“If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped, the product involved in this recall,” the company said.
