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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 25, 1998

PRODUCT
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 #0517-7630-03
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.

Recall #D-071/072-8.

CODE

Lot numbers: a) 7855 EXP 5/99; b) 7846 EXP
11/99.

MANUFACTURER

American Regent Laboratories, Inc., Shirley,
New York.

RECALLED BY
Manufacturer, by fax on January 6, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

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.

REASON

Mispackaging - Correctly labeled concentrated
sodium chloride injection vials placed into
intermediate cartons labeled as Acetylcysteine
Solution.

 

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.