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April 5, 2000

American Pharmaceutical Partners Inc. Recalls Calcium Gluconate Injection

Melrose Park, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that American Pharmaceutical Partners Inc. is recalling Calcium Gluconate Injection because of particulate matter in some vials.

The Calcium Gluconate Injection, USP, 10%, in 50-mL single dose and in 200-mL pharmacy bulk packages, was distributed under the following labels:
Fujisawa - NDC #0469-0311-50 and 0469-0311-63
APP - NDC #63323-311-63.

According to the FDA, approximately 180,000 vials were distributed nationwide, Uruguay, Hong Kong, Israel and in Singapore. The recalled product bears the lot numbers of  180156, 180180, 180232, 180274, 180170, 180265, 180458, 180538, 180657, 190441, 190629, 190736, 190836.  The firm estimated that 25% of the product remained on market at time of recall initiation.

This ongoing Class III recall was initiated by American Pharmaceutical Partners, Inc., by letter dated March 10, 2000.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-257-0

Notice of this product warning was sent via email to SafeMail subscribers April 5, 2000.

Selected Recent Recalls

Health Professional:

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

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