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May 24, 2000

American Pharmaceutical Partners Recalls Vancomycin Hydrochloride

Melrose Park, IL (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that American Pharmaceutical Partners Inc., is conducting a recall of its Vancomycin Hydrochloride, USP, Sterile, 10 g, in pharmacy bulk package.  The recall is being conducted because of moisture failure during stability testing.

The product is a prescription for IV Infusion after dilution and can identified by Lot Numbers: 180266, 180432, 180449, 180465, 180490, 180635, 180647, 180693.

FDA stated in its report that 44,006 100-mL vials were distributed nationwide and that the firm estimated that 20 percent of the product remained on market at time of recall initiation.

This ongoing Class III recall was initiated by the company, by letter dated April 6, 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-362-0
NDC #0469-3140-61

Notice of this product warning was sent via email to SafeMail subscribers May 24, 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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