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SafetyAlerts
September 20, 2000

Leucovorin Calcium Injection Recalled

Irvine, CA (SafetyAlerts) - The Food and Drug Administration (FDA) has announced that Gensia Sicor Pharmaceuticals, Inc., is recalling its Leucovorin Calcium Injection, USP, 500mg/50ml single dose vial because of Particulates (stability).

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

PRODUCT
Leucovorin Calcium Injection, USP, 500mg/50ml single dose vial, Rx drug product in an amber glass vial.

Recall #D-467-0.

CODE
LOT #99K202 EXP 08/2001.

MANUFACTURER
Gensia Sicor Pharmaceuticals, Inc., Irvine, California, by letter on August 18, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Wisconsin, West Virginia, District of Columbia.

QUANTITY
13,132 vials were distributed.

 
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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