NAFDAC Alert: Recall of Sodium Chloride Intravenous Solution Bag Due to Leakages

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The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public that Canadian-based Fresenius Medical Care (FMC), manufacturer of Sodium Chloride Injection 0.9% USP, 1000mL had recalled 3 lots of the product due to life threatening leakages in the solution bags.

Sodium Chloride Injection 0.9% USP, is indicated as a source of water and electrolytes for fluid replenishment as required by the clinical condition of the patient and is labelled for IV use as a single dose. Unused portions should be discarded.  It is also used as a priming solution in haemodialysis procedures.

Possible associated risks

Leakage of intravenous solution bags may result in a breach of sterility, microbial contamination, or air embolism from air introduced to the IV system. If used in IV admixtures, there is potential for delivery of a more concentrated drug solution than intended.

Details of affected products

Manufacturer’s Address: 
Fresenius Medical Care
45 Staples Avenue, Suite 110
Richmond Hill, ON, L4B 4W6

Product Name Product code DIN Package format Lot
Expiry date
0.9% Sodium Chloride Injection USP CNS-10109 02311798 1000 mL 16EU05011



May 31, 2017

Healthcare providers’ action

  • Healthcare providers in possession of the affected lots of the products should immediately stop their distribution and use; and return them to the nearest NAFDAC office for appropriate regulatory action.
  • Healthcare providers and patients should report adverse reactions associated with the use of these product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via
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About Bob Aroture 559 Articles
Bob is a Senior Editor and Content Development Manager at Nigerian Law Intellectual Property Watch. He holds a BS degree, with a major in biochemistry. He works directly with the Newsroom Team. His focus areas are technology and innovation, and pharmaceutical technology. Email: