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
Fresenius Medical Care
45 Staples Avenue, Suite 110
Richmond Hill, ON, L4B 4W6
|Product Name||Product code||DIN||Package format||Lot
|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 firstname.lastname@example.org