Recall of CF drugs

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Schering Has Recalled Various products

(http://www.safetyalerts.com/Default.htm " >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.

AmeriSource Has Recalled Proventil and Theo-Dur

(http://www.safetyalerts.com/Default.htm " >SafetyAlerts) -

The Food and Drug Administration (FDA) has released the

following information.

PRODUCT

a) Proventil brand of (albuterol sulfate, USP) Repetabs brand of

extended-release Tablets, 4 mg, bottles of 100, Rx only.

Recall # D-330-2;

Theo-Dur (THEOPHYLLINE(Anhydrous), Extended-Release Tablets 200 mg,

bottles of 100 and 500, Rx only. Recall # D-331-2.

CODE

a) PROVENTIL

Lot Number Exp Date

15920 APR 02

16224 APR 02

16678 MAY 02

16745 MAY 02

010804 JUL 02

THEO-DUR

Lot Number Exp Date

16924 MAY 02

16228B MAY 02

16228A MAY 02

16411 MAY 02

RECALLING FIRM/MANUFACTURER

Recalling Firm: AmeriSource Health Services Corp., Columbus, OH, by

letter

and fax on June 4, 2002.

Manufacturer: Schering Corp., Kenilworth, NJ. Firm initiated recall is

ongoing.

REASON

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

manufacturer.

VOLUME OF PRODUCT IN COMMERCE

8,406 bottles (Proventil); and 3,318 bottles (Theo-Dur).

DISTRIBUTION

Nationwide.