September 13, 2000Sodium Bicarbonate Injection
Recalled by American Pharmaceutical Partners, Inc.
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.
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
NDC #63323-006-50. Recall #D-448-0.
Lot #190365 EXP 11/00.
American Pharmaceutical Partners, Inc., Melrose Park, Illinois.
Manufacturer, by letter dated July 26, 2000. Firm-
initiated recall ongoing.
37,500 vials were distributed; firm estimated that little if any remains on the market.
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