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January 18, 2000

American Pharmaceutical Partners, Inc. Recalls Oxytocin Injection

Grand Island, NY (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that American Pharmaceutical Partners, Inc. is recalling Oxytocin Injection, USP (synthetic) because of subpotency.

The recalled product, indicated for the initiation or improvement of uterine contractions to induce labor, was distributed in 10 USP units/mL, 1 mL, (3cc plastic vial) have the NDC #N0469-002-061 and can be identified by the lot number #392002 and the expiration date of 04/00.

According to FDA, over 294,000 units were distributed nationwide.  The firm estimates none remains on the market.

This ongoing Class II recall was initiated by American Pharmaceutical by letter dated December 20, 1999.  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-204-0

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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