5% Dextrose, 0.9% Sodium Chloride IV Solution Recall [US]

US FDA RecallUS/Silver Spring: Baxter Healthcare recalls some 5% Dextrose Injection, USP Intravenous (IV) Solutions and 0.9% Sodium Chloride Injection, USP Intravenous (IV) Solutions due to particulate matter hazard. FDA: http://ht.ly/s7XhF

Direct link: http://www.fda.gov/Safety/Recalls/ucm379914.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Intravenous (IV) Drug Solutions are subject to this recall: 

  • 5% Dextrose Injection, USP; size: 100 mL; product code: 2B0089; NDC: 0338-0017-38; lot number: P285288; expiry: Nov-13
  • 0.9% Sodium Chloride Injection, USP; size: 50 mL; product code: 2B1308; NDC: 0338-0049-31; lot number: P297283; expiry: Aug-14
  • 0.9% Sodium Chloride Injection, USP; size: 100 mL; product code: 2B1302; NDC: 0338-0049-18; lot number: P292326; expiry: Apr-14 and lot number: P293993; expiry: May-14
  • 0.9% Sodium Chloride Injection, USP; size: 100 mL; product code: 2B1309; NDC: 0338-0049-38 lot number: P293514; expiry: Apr-14

According to the FDA, injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.

Products affected by this recall were packaged in flexible plastic containers with 96 containers per carton. Affected product was distributed to healthcare centers and distributors in Saudi Arabia, Singapore, United Arab Emirates, and the United States and Puerto Rico.


Recalls Direct RIN: 2013-2917
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