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SafetyAlerts
April 11, 2002

Schering Corp Has Recalled Clartin-D 12 Hour Tablets

Kenilworth, NJ  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Schering Corp has recalled Clartin-D 12 Hour Tablets.

PRODUCT
Clartin-D 12 Hour Tablets, (5 mg Loratadine/120 mg pseudoephedrine sulfate, USP), Extended release tablets, Rx only, 100 tablet bottles, 100 unit dose tablets, and 30 tablet blister packs. Recall # D-228-2.

CODE
All lots with the prefix number of "0" or "1" (representing
the years 2000 and 2001 respectively). Also lots 9-JRP-
313, 9-JRP-338, 9-JRP-2040, 9-JRP-2041 and 9-JRP-2042.

Batch Exp. Date Batch Exp. Date Batch Exp. Date

0-JRP-134 04/2003 0-JRP-256 10/2003 1-JRP-2045 05/2004
0-JRP-153 04/2003 1-JRP-10 12/2003 1-JRP-2047 04/2004
0-JRP-2000 07/2002 1-JRP-113 02/2004 1-JRP-2049 05/2004
0-JRP-2001 10/2002 1-JRP-2000 06/2003 1-JRP-2052 03/2004
0-JRP-2003 08/2002 1-JRP-2004 06/2003 1-JRP-2053 03/2004
0-JRP-2005 10/2002 1-JRP-2005 10/2003 1-JRP-2055 05/2004
0-JRP-2006 01/2003 1-JRP-2007 08/2003 1-JRP-2057 03/2004
0-JRP-2008 12/2002 1-JRP-2009 10/2003 1-JRP-2058 05/2004
0-JRP-2009 01/2003 1-JRP-2011 10/2003 1-JRP-2060 03/2004
0-JRP-2010 02/2003 1-JRP-2012 05/2003 1-JRP-2061 05/2004
0-JRP-2011 02/2003 1-JRP-2013 10/2003 1-JRP-2062 05/2004
0-JRP-2013 02/2003 1-JRP-2014 12/2003 1-JRP-2063 05/2004
0-JRP-2016 02/2003 1-JRP-2015 10/2003 1-JRP-2064 05/2004
0-JRP-2017 02/2003 1-JRP-2016 01/2003 1-JRP-2065 05/2004
0-JRP-2022 03/2003 1-JRP-2019 12/2003 1-JRP-2066 05/2004
0-JRP-2023 02/2003 1-JRP-2020 01/2004 1-JRP-2067 05/2004
0-JRP-2025 03/2003 1-JRP-2021 08/2003 1-JRP-2068 05/2004
0-JRP-2027 04/2003 1-JRP-2022 01/2004 1-JRP-292 01/2003
0-JRP-2028 04/2003 1-JRP-2023 01/2004 1-JRP-324 01/2003
0-JRP-2029 03/2003 1-JRP-2024 01/2004 1-JRP-46 01/2004
0-JRP-2031 04/2003 1-JRP-2025 01/2004 1-JRP-52 01/2004
0-JRP-2033 04/2003 1-JRP-2026 01/2004 9-JRP-2040 09/2002
0-JRP-2034 04/2003 1-JRP-2027 01/2004 9-JRP-2041 10/2002
0-JRP-2036 05/2005 1-JRP-2028 08/2003 9-JRP-2042 10/2002
0-JRP-2039 02/2003 1-JRP-2029 02/2004 9-JRP-313 11/2002
0-JRP-2047 03/2003 1-JRP-203 09/2002 9-JRP-338 11/2002
0-JRP-2048 03/2003 1-JRP-2030 01/2004
0-JRP-2049 05/2003 1-JRP-2031 01/2004
0-JRP-2050 05/2003 1-JRP-2032 02/2004
0-JRP-2051 05/2003 1-JRP-2033 02/2004
0-JRP-2052 05/2003 1-JRP-2035 02/2004
0-JRP-2053 06/2003 1-JRP-2036 03/2004
0-JRP-2054 07/2003 1-JRP-2037 03/2004
0-JRP-2055 07/2003 1-JRP-2040 03/2004
0-JRP-2056 05/2003 1-JRP-2044 04/2004.

RECALLING FIRM/MANUFACTURER
Schering Corp., Kenilworth, NJ, by letter on February 19, 2002.
Firm initiated recall is ongoing.

REASON
Dissolution failure; pseudoephedrine sulfate component (5th hour/18 month stability).

VOLUME OF PRODUCT IN COMMERCE
7,875,653 units.

DISTRIBUTION
TX, PA, CA, DE and VA
.

 
Selected Recent Recalls


Health Professional:

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During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.