Haemonetics 0.9 % Sodium Chloride Recall
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Questions & Answers
Side Effects & Adverse Reactions
Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, servere renal insufficiency, and in clinical states in which there exist ederna with sodium retention. In patients with diminshed renal function administration of Sodium Chloride Injection, USP may result in sodium retention.
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride in hemodialysis procedures.
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Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. The pH is 4.5 to 7.0. Composition, osrnolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L. Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (cale). It contains 154 mEq/L sodium and 154 mEQ/L chloride. The amount of water that can permeate from inside the container into the overlap in insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP) up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.