Voluntary Recall of Unapproved Urokinase Product - (Medicine Shoppe) - 9/28/2000
DATE RECALL INITIATED:
September 28, 2000
LOT NUMBERS / USE BY DATES:
UNAPPROVED Urokinase Product
|00I0701 3/7/2001||00I0401 3/4/2001||00I0101 3/1/2001|
|00H2101 2/21/2001||00H1401 2/14/2001||00H0701 8/7/2001|
|00G3101 1/31/2001||00G2401 1/24/2001||00G1701 1/17/2001|
|00G1001 1/10/2001||00F2901 12/29/2001||00F2601 12/26/2001|
|00F1901 12/19/2001||00E2401 11/24/2001||00E2201 11/22/2001|
|00E2001 11/20/2001||00E1001 11/10/2001||00E0801 11/8/2001|
|00D1701 10/17/2001||00D1501 10/15/2001||00D1301 10/13/2001|
1567 N. Eastman Road
Kingsport, TN 37664
All lots of Urokinase that have not exceeded the use by date are being recalled. The recall was initiated because the product has not been approved by the Food and Drug Administration, and therefore there is no assurance that the product is safe and effective for its intended use. The drug was also manufactured under conditions which are not in compliance with Current Good Manufacturing Practices which could increase the risk of transmitting infectious agents.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.