Proventil Repetabs, Theo-Dur Extended Release Tabs, Theophylline Extended Release Tabs, Uni-Dur Extended  Release Tabs - Manufacturers Schering and Warrick


SafetyAlerts August 28, 2002

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