|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
February 25, 1998
a) Acetylcysteine Solution, USP 20% (200 mg/ml) 30 ml vials, packaged in units of
3, Rx, Mucolytic; for bronchial indications such as asthma and tuberculosis. NDC
b) Concentrated Sodium Chloride Injection, USP, 23.4% (234 mg/ml) in 30 ml single dose
vials, Rx, additive in parenteral fluid therapy for use in patients who have problems with
Sodium electrolytic intake or excretion. NDC #0517-2930-23.
Lot numbers: a) 7855 EXP 5/99; b) 7846 EXP
American Regent Laboratories, Inc., Shirley,
Manufacturer, by fax on January 6, 1998.
Firm-initiated recall ongoing.
a) 44,097 vials; b) 163,375 vials were
distributed; firm estimated that a) 75-80
percent; b) 80 percent of the product remained
on market at time of recall initiation.
Mispackaging - Correctly labeled concentrated
sodium chloride injection vials placed into
intermediate cartons labeled as Acetylcysteine