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SafetyAlerts
September 13, 2000

Aventis Recalls Certain Lots of Synercid(r) I.V.

Kansas City, MO (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Aventis Pharmaceuticals, Inc., is recalling Synercid(r) I.V. (Quinupristin and Dalfopristin for injection), 500 mg, in 10 mg single dose vials due to lack of assurance of sterility (seal integrity).

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Synercid(r) I.V. (Quinupristin and Dalfopristin for injection), 500 mg, in 10 mg single dose vial, lyophilized, Rx indicated for the treatment of patients with serious or life-threatening infections associated with
vancomycin-resistant Enterococcus faecium (VREF) bacteremia.

NDC #0075-9051-10. Recall #D-450-0.

CODE
9G1439 9G1471 9H1854 9J2122 0A1297
9G1440 9G1438 9H1855 9L2562 0A1316
9G1470 9G1441 9H1853 0A1298 0A1419.

MANUFACTURER
Catalytica Pharmaceuticals, Inc., Greenville, North Carolina.

RECALLED BY
Aventis Pharmaceuticals, Inc., Kansas City, Missouri, by letter dated July 20, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Spain, Canada.

QUANTITY
582,130 vials were distributed.

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

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