November 21, 2000American Health Packaging
Recalls Heparin Sodium Injection
OH (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that AmeriSource Health Services Corporation, doing
business as American Health Packaging (AHP) is recalling certain Zagam® Tablets because
of a lack of assurance of sterility.
This is the first public notice of
this Class II
issued by FDA.
Heparin Sodium Injection, USP, 5000 USP units per 0.5 mL in 1 mL tubex per
10,000 USP units, Rx.
Lot Numbers: 10945 EXP 02/01 and 10962 EXP 02/01.
Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania (responsible firm).
AmeriSource Health Services Corporation, doing business as American Health Packaging
(AHP), Columbus, Ohio (repacker/relabeler/distributor), by letter mailed on September 26,
2000. Firm-initiated recall ongoing.
Ohio, New Jersey, Tennessee, Florida, Minnesota, Kentucky.
60 bags (1,500 vials) were distributed.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafetyAlerts subscribers November
21, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
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