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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 31, 1999

PRODUCT
Nutrilyte, for IV use after Dilution, Multi-Electrolyte Concentrate-(Electrolytes mEq/20mL: Acetate 40.6; Potassium 40.6; Chloride 33.6; Sodium 25; Magnesium 8; Calcium 5; Gluconate 5) 20 mL single dose vial, Rx 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. It is also indicated as a source of replacement electrolytes for the depleted adult during parenteral therapy. NDC #0517-3120-25. Recall #D-151-9.

CODE
Lot #8342 EXP 5/00.

MANUFACTURER
Luitpold Pharmaceuticals, Inc., also known as American Regent Laboratories, Inc., Shirley, New York.

RECALLED BY
Manufacturer, by telephone on February 10, 1999, followed by letter. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
61,825 vials were distributed.

REASON
Particulate matter.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.