SHIRLEY, N.Y., June 15, 2011 /PRNewswire/ — American Regent is
conducting a voluntary nationwide recall to the user and consumer
level of the following product:
Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL
Single Dose Vial, Lot # 0362, Expiration Date: May 2012,
NDC # 0517-2930-25
PLEASE NOTE: This voluntary nationwide
recall, initiated on June 14, 2011 to the user and consumer level
is for lot # 0362 only. No other sizes or lots of Concentrated
Sodium Chloride Injection, USP are subject to this voluntary
recall.
This voluntary recall was initiated because some of the vials of
this lot contain visible particulates. Potential adverse
events after intravenous administration of solutions containing
particulates may include disruption of blood flow within small
blood vessels in the lung, localized inflammation (swelling and
redness due to accumulation of inflammatory cells), and granuloma
formation. American Regent is undertaking this voluntary
recall in consideration of the potential for safety issues if this
lot of product is administered to patients.
Concentrated Sodium Chloride Injection, USP, 23.4% is indicated
as an additive in parenteral fluid therapy for use in patients who
have special problems of sodium electrolyte intake or excretion. It
is intended to meet the specific requirement of the patient with
unusual fluid and electrolyte needs.
The product was distributed to wholesalers and distributors
nationwide.
Hospitals, infusion centers, clinics and other healthcare
facilities should not use American Regent Inc., Concentrated Sodium
Chloride Injection, USP, 23.4%, Lot # 0362 for patient care and
should immediately quarantine any product for return.
As is standard practice, and as stated in the Concentrated
Sodium Chloride Injection, USP Product Package Insert,
“Parenteral drug products should b
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