January 18, 2000American 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
Safety Alerts compiles
comprehensive safety recall information for the United States. SafeMail is a free email
service to warn consumers of faulty products and contaminated foods. For complete
information regarding current recalls, past recalls and timely product warning
notification visit: www.safetyalerts.com.