Medication Monitor

Generic Name (Trade Name—Company)
November 27, 2018

Sodium chloride injection 0.9%

(No trade names—Fresenius Kabi USA)
Product recalled because stoppers for vials contain natural rubber latex

Fresenius Kabi USA is voluntarily recalling 163 lots of sodium chloride injection 0.9%, 10 mL fill in a 10-mL vial; and sodium chloride injection 0.9%, 20 mL fill in a 20-mL vial. The product is being recalled because the stoppers contain natural rubber latex.

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 that could result in hospitalization or death.

To date, Fresenius Kabi USA has not received any reports of adverse events related to this recall. 

See the tables for a full list of the affected lots, including lot numbers and expiration dates.