|Product Description:||Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311|
|Voluntary/Mandated:||Voluntary: Firm Initiated|
|Initial Firm Notification:||Letter|
|Distribution Pattern:||Nationwide, Puerto Rico and Spain|
|Product Quantity:||5,592 units|
|Reason For Recall:||Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.|
|Recall Initiation Date:||20131121|
Hyperlyte Cr Recall
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Questions & Answers
Side Effects & Adverse Reactions
Strongly hypertonic solution. Must be properly diluted and thoroughly mixed before injection.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contains no phosphate. Patients receiving TPN solutions containing concentrated dextrose may also require phosphate in addition to Hyperlyte® CR.
Each 20 mL dose contains 20 mEq of potassium. Patient requirements should be carefully evaluated prior to the addition of any potassium salt to a solution containing Hyperlyte® CR.
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.
Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended.
In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention.
Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.
Solutions containing acetate should be used with great care in patients with metabolic or respiratory alkalosis. The administration of acetate should be done with great care in those conditions in which there is an increased level or an impaired utilization of acetate, such as severe hepatic insufficiency.
There is currently no legal information available for this drug.
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.
Hyperlyte® CR is indicated for use as a supplement to parenteral nutritional solutions containing amino acids, dextrose and/or other calorie sources delivered by central venous or peripheral infusion, to facilitate amino acid utilization and maintain electrolyte balance in adults.
Hyperlyte® CR (Multi-Electrolyte Concentrate) is also indicated as a source of replacement electrolytes for the depleted adult patient during parenteral therapy.
There is currently no drug history available for this drug.
A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion.
Hyperlyte® CR (Multi-Electrolyte Concentrate) is a sterile, nonpyrogenic, concentrated solution of intra- and extracellular electrolytes, excluding phosphate. No bacteriostatic or antimicrobial agent has been added.
Each 20 mL contains: Potassium Acetate USP 1.96 g; Sodium Chloride USP 1.17 g; Sodium Acetate Trihydrate USP 0.68 g; Magnesium Chloride Hexahydrate USP 0.51 g; Calcium Chloride Dihydrate USP 0.37 g; Water for Injection USP qs
pH adjusted with Glacial Acetic Acid USP as needed
pH: 5.2 (5.0-5.4); Calculated Osmolarity: 5500 mOsmol/liter
Concentration of Electrolytes (mEq/20 mL dose): Sodium 25; Potassium 20; Calcium 5; Magnesium 5; Chloride 30; Acetate 30
The formulas of the active ingredients are:
Potassium Acetate USP
Sodium Chloride USP
Sodium Acetate Trihydrate USP
Magnesium Chloride Hexahydrate USP
Calcium Chloride Dihydrate USP