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U.S. Department of Health and Human Services

Drugs

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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
00D1101 10/11/2001

MANUFACTURER:

Medicine Shoppe
1567 N. Eastman Road
Kingsport, TN 37664

REASON:

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.