Fresenius Initiates Voluntary Recall of Sodium Chloride Injection Products
Fresenius Kabi, a specialty and generic pharmaceuticals company, is voluntarily recalling 163 lots of sodium chloride injection (USP, 0.9%, 10 mL) and sodium chloride injection (USP, 0.9%, 20 mL) to the consumer level due to natural rubber latex found in the vial stoppers. The notice was posted by the US Food and Drug Administration (FDA) on November 20, 2018 in a recall report.
The product insert states that stoppers for both the 10-mL and the 20-mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20-mL vial also state that the stoppers do not contain latex. For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death, according to information from the FDA. As of November 20, 2018, Fresenius Kabi had not received any reports of adverse events related to this recall.
Sodium chloride injection (USP, 0.9%) is indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection. It is also indicated for use in flushing of intravenous catheters.
Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of the recalled product.