April 5, 2000American 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
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
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.
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