Fresenius recalls sodium chloride injection over possible allergic reaction

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Esben_H)
(Image: Getty/Esben_H)

Related tags Recall Injection Syringe allergy

Fresenius Kabi voluntarily recalled 163 lots of sodium chloride injections, after the presence of latex was found within its packaging.

The company recalled its sodium chloride injections, USP, 0.9% 10 mL fill, and 20 mL fill, after product inserts stated that the stoppers do not contain rubber latex, despite it being present within the stoppers.

Individuals with a severe allergy to latex may have an anaphylactic response to the presence of latex, which could lead to hospitalization or death. The company stated that, to date, there have been no reports of adverse events related to this recall.

The sodium chloride injections are indicated for the diluting or dissolving of drugs for intramuscular, intravenous, or subcutaneous injection. The injections are also labeled for flushing of intravenous catheters.

Fresenius stated it notified its distributors and customers by letter and is arranging for the return of the recalled product.

We reached out to Fresenius for comment but the company did not reply at this time.

In 2015, Fresenius was fined after a faulty insulin syringe​ led to a diabetic patient’s death. The company paid €500,000 ($778,000), after the incident in which a man was without insulin for 13 hours leading to diabetic ketoacidosis and multiple organ failure. At the time, the manufacturer of the insulin was also fined.

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