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SafetyAlerts
September 13, 2000

Sodium Bicarbonate Injection Recalled by American Pharmaceutical Partners, Inc.

Melrose Park, IL (SafetyAlerts) - The Food and Drug Administration (FDA) said today that American Pharmaceutical Partners, Inc., is recalling its Sodium Bicarbonate Injection, USP, 8.4% (84 mg/mL), for IV use only, in 50 mL single dose vial due to "lack of assurance of sterility" (particle counts exceeding action level).

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Sodium Bicarbonate Injection, USP, 8.4% (84 mg/mL), for IV use only, in 50 mL single dose vial, Rx for correction of metabolic acidosis and other conditions requiring systemic alkalization.

NDC #63323-006-50. Recall #D-448-0.

CODE
Lot #190365 EXP 11/00.

MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, Illinois.

RECALLED BY
Manufacturer, by letter dated July 26, 2000. Firm-
initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
37,500 vials were distributed; firm estimated that little if any remains on the market.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.