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SafetyAlerts
August 28, 2002

Schering Has Recalled Various products

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
Proventil® brand of (albuterol sulfate, USP) Repetabs® brand of extended-
release Tablets, 4 mg, unit dose of 100, bottles of 100 and 500, Rx only,
Recall # D-392-2;
Theo-Dur® (theophylline (anhydrous)) extended-release Tablets 200 mg,
unit dose of 100, bottles of 100, 500, 1000 and 5000, Rx only, Recall #
D-393-2;
Also sold as:
THEOPHYLLINE (Anhydrous) Extended-Release Tablets, 200 mg, bottles of
100, 500 and 1000, Rx only,
Theo-Dur® (theophylline (anhydrous)) extended-release tablet, 300 mg,
unit dose of 100, bottles of 100, 500, 1000 and 5000,
Recall # D-394-2;
Also sold as:
THEOPHYLLINE (Anhydrous) Extended-Release Tablets, 300 mg,
bottles of 100, 500 and 1000, Rx only,
Theo-Dur® (theophylline (anhydrous)) extended-release tablet,
450 mg, unit dose of 100, bottles of 100, Rx only,
Recall # D-395-2;
Also sold as:
THEOPHYLLINE (Anhydrous) Extended-Release Tablets, 450 mg,
bottles of 100, Rx only
Uni-Dur® (theophylline) Extended-release Tablets, 600 mg, bottles of 100,
Rx only, Recall # D-396-2.

CODE
Schering Proventil® Repetabs® brand of albuterol sulfate, USP extended
release tablets:
Lot Number Expiration Date Lot Number Expiration Date
0-RDR-89 November 2002 0-RDR-2014 June 2002
0-RDR-2005 April 2002 0-RDR-58 July 2002
0-RDR-2009 May 2002 1-RDR-2001 July 2002
0-RDR-2013 June 2002 1-RDR-2004 July 2002
0-RDR-72 July 2002 1-RDR-2004 November 2002
0-RDR-2004 April 2002 1-RDR-2000 July 2002
0-RDR-2006 April 2002 1-RDR-2002 July 2002
0-RDR-2008 May 2002 1-RDR-2003 July 2002
0-RDR-2010 May 2002 1-RDR-2005 November 2002
0-RDR-2011 April 2002 1-RDR-2006 July 2002
0-RDR-2012 May 2002 1-RDR-2007 November 2002

Schering Theo-Dur® brand of theophylline, USP:
Lot Number Expiration Date Lot Number Expiration Date
0-KHP-439 (200mg) April 2002 0-FCY-396 (300mg) April 2002
0-KHP-440 (200mg) April 2002 0-FCY-521 (300mg) April 2002
0-KHP-515 (200mg) May 2002 0-FCY-673 (300mg) August 2002
0-KHP-581 (200mg) July 2002 0-FCY-497 (300mg) April 2002
0-KHP-395 (200mg) April 2002 0-FCY-674 (300mg) August 2002
0-KHP-524 (200mg) June 2002 1-FCY-049 (300mg) November 2002
0-KHP-675 (200mg) August 2002 0-PXG-526 (300mg) August 2002
0-KHP-462 (200mg) May 2002 0-PXG-735 (300mg) October 2002
0-KHP-736 (200mg) August 2002 0-PXG-746 (300mg) April 2002
0-FCY-379 (300mg) April 2002

Warrick Theophylline tablets, USP:
Lot Number Expiration Date Lot Number Expiration Date
0-PHN-415 (200mg) April 2002 0-CGE-520 (300mg) June 2002
0-PHN-599 (200mg) August 2002 0-CGE-582 (300mg) August 2002
0-PHN-464 (200mg) May 2002 0-CGE-453 (300mg) May 2002
0-PHN-522 (200mg) May 2002 0-GNB-371 (450mg) May 2002
0-PHN-404 (200mg) April 2002 0-GNB-449 (450mg) August 2002
0-CGE-512 (300mg) May 2002 0-GNB-600 (450mg) August 2002
1-CGE-037 (300mg) August 2002 0-GNB-703 (450mg) August 2002
0-CGE-463 (300mg) May 2002

Schering Uni-Dur® brand of theophylline, USP:
Lot Number Expiration Date
0-HKH-719 (600mg) June 2002.

RECALLING FIRM/MANUFACTURER
Schering Corp., Kenilworth, NJ, by letters dated May 6, 2002.
Firm initiated recall is ongoing.

REASON
Dissolution; failures at the sixth and eighth hour (stability).

VOLUME OF PRODUCT IN COMMERCE
Proventil Repetabs: 205,591; Theo-Dur: 191,505;
Uni-Dur: 7,304, Warrick Theophylline: 616,795.

DISTRIBUTION
Nationwide and Puerto Rico.

 
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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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.