Epinephrine Mist Kit and Claritin D recalls

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SafetyAlerts
April 11, 2002
Alpharma USPD Has Recalled Epinephrine Mist Kit, Epinephrine Inhalation Aerosol
Baltimore, MD (SafetyAlerts) - The Food and Drug Administration (FDA) said that Alpharma USPD has recalled Epinephrine Mist Kit, Epinephrine Inhalation Aerosol.
PRODUCT
Epinephrine Mist Kit, Epinephrine Inhalation Aerosol, USP, 5.5 mg/mL 1/2 Fl. Oz., Kit contains nebulizer/actuator packaged with vial. Recall # D-221-2.
Epinephrine Mist-Epinephrine Inhalation Aerosol USP Refill, 5.5 mg/mL, packaged in 0.5 ounce plastic coated glass vials, 1 vial per box, 24 boxes/carton. Recall # D-222-2.
CODE
Kit with Inhaler (1/2 oz)
Lot Number Expiration Date
RB0166 28-Feb-02
RB0170 28-Feb-02
RB0171 31-Mar-02
RB1200 31-Jan-03
RB1201 31-Jan-03
RB1204 28-Feb-03
RB1205 28-Feb-03
RB1207 28-Feb-03
RB1208 28-Feb-03
RC0176 30-Apr-02
RC1209 28-Feb-03
RC1213 31-Mar-03
RD0178 30-APR-02
RD0180 31-Mar-02
RD0182 30-Mar-02
RD0183 30-Mar-02
RF1414 30-Mar-03
RH0543 30-Jun-02
RH0544 31-Jul-02
RH0547 31-Jul-02
RH0548 31-Jul-02
RJ1669 30-Jun-03
RJ1671 30-Jun-03
RJ1672 30-Jun-03
RK0551 31-Aug-02
RK0552 31-Aug-02
RK0553 31-Aug-02
RK0689 30-Sep-02
RK1676 31-Jul-03
RK1677 31-Jul-03
RK1680 31-Aug-03
RL0690 30-Sep-02
RL0691 30-Sep-02
RN0698 31-Oct-02
RN0699 31-Oct-02
RN0700 31-Oct-02
RP0834 31-Oct-02
RP0835 31-Oct-02
RS0840 31-Jan-03
RS0841 31-Jan-03
Refill (1/2 oz)
Lot Number Expiration Date
RB0167 28-Feb-02
RB0168 28-Feb-02
RB0169 28-Feb-02
RB1202 28-Feb-03
RB1203 28-Feb-03
RB1206 28-Feb-03
RC0172 31-Mar-02
RC0173 03-Jan-00
RC0177 28-Feb-02
RC1210 31-Mar-03
RC1211 31-Mar-03
RC1212 31-Mar-03
RC1214 31-Mar-03
RD0179 31-Mar-02
RD0181 30-Mar-02
RD0410 31-Mar-03
RD1405 30-APR-03
RD1406 31-May-03
RD1407 31-May-03
RD1408 31-May-03
RD1409 31-May-03
RF1410 31-Mar-03
RF1412 31-Mar-03
RF1413 31-Mar-03
RH0542 30-Mar-02
RH0545 31-Jul-02
RH0546 31-Jul-02
RH0549 31-Aug-02
RH0550 31-Aug-02
RJ1670 30-Jun-03
RJ1674 30-Jun-03
RK0554 31-Aug-02
RK0555 31-Aug-02
RK0688 31-Aug-02
RK1675 31-Jul-03
RK1678 31-Jul-03
RK1679 31-Aug-03
RL0692 30-Sep-02
RL0693 30-Sep-02
RL0694 30-Sep-02
RL0695 31-Oct-02
RL1977 31-Aug-03
RN0696 31-Oct-02
RN0701 31-Oct-02
RP0833 31-Oct-02
RP0836 30-Nov-03
RP0837 30-Nov-03
RP0838 31-Jan-03
RS0839 31-Jan-03
RS0841 31-Jan-03
RS0841 31-Jan-03
RS0842 31-Jan-03
RS0843 31-Jan-03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpharma USPD, Baltimore, MD, by letter on February 26, 2002.
Manufacturer: Armstrong Laboratories, Inc., West Roxbury, MA.
Firm initiated recall is ongoing.
REASON
Failure to test Purified Water ingredient for all microbial
specifications.
VOLUME OF PRODUCT IN COMMERCE
4,333,356 units.
DISTRIBUTION
Nationwide.

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.

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.