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SafetyAlerts
April 11, 2002

Allscripts Healthcare Solutions Has Recalled Claritin-D 12 Hour

Libertyville, IL  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Allscripts Healthcare Solutions has recalled Clartin-D 12 Hour Tablets.

PRODUCT
Claritin-D 12 Hour Extended Release Tablets, (5 mg loratadine/120 mg pseudoephedrine sulfate, USP); Rx Only, Packaged in
a) 20 tablet bottle (Product No. 4094-0);
b) 14 tablet bottle (Product No. 4094-1);
c) 60 tablet bottle (Product No. 4094-2);
d) 10 tablet bottle (Product No. 4094-3).
Recall # D-229-2.

CODE
a) 0042080, 0055010, 0101117, 0146013, 0160042, 0174010, 0195010, 0244057, 0269160, 0291101, 0318124, 0334073, 0349135, 0363122, 1025185, 1046228, 1067144, 1086185, 1102132, 1122197, 1142124, 1157100, 1193162, 1220148, 1234121, 1254105, 1262128, 1281162, 1317148, 1325191, 1330163, 1354100, 2015153, 2023112;

b) 0039104, 0063047, 0117108, 0154036, 0189024, 0208100, 0264132, 0290115, 0320132, 0332205, 0335205, 0341185, 1360424, 1362043, 2011112, 2018088

c) 0084051, 0098022, 0111068, 0157159, 0166112, 0231024, 0249120, 0259030, 0278118, 0307047, 0343028, 1003155, 1019179, 1032136, 1068023, 1078146, 1099136, 1123198, 1129153, 1141136, 1151198, 1170147, 1229041, 1247163, 1269187, 1276189, 1290107, 1306025, 1338183, 1348039, 2009151, 2042179

d) 0049098, 0053185, 0234125, 0238040, 0341212, 0354178, 1109179, 1115217, 1117053, 1124051, 1124120, 1129103, 1131049.

RECALLING FIRM/MANUFACTURER
Allscripts Healthcare Solutions, Libertyville, IL, by letters dated February 28, 2002. Firm initiated recall is ongoing.

REASON
Dissolution failure (at manufacturer, Schering Corp); pseudoephedrine sulfate component (5th hour/18 month stability).

VOLUME OF PRODUCT IN COMMERCE
84,392 tablets.

DISTRIBUTION
Nationwide
.

 
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During 2000 there were over
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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.