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SafetyAlerts
December 26, 2000

Numerous Brands of Pseudoephedrine Decongestant Recalled

Carson, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Leiner Health Products is recalling its Pseudoephedrine HCL Tablets because of failure to validate manufacturing process (sequence of addition of components).

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
Pseudoephedrine HCL Tablets, 30 mg, in 24, 32, 48, 96, and 384-count bottles, OTC under the following labels:
Finast Suphedrine Nasal Decongestant, Super G Suphedrine Nasal Decongestant, Stop & Shop Suphedrine Nasal Decongestant, Family Pharmacy Pseudoephedrine, Medallion Suphedrine Nasal Decongestant, Your 1st Choice for Value Suphedrine Nasal Decongestant, Brooks Suphedrine Nasal Decongestant, DeMoulas Market Basket Suphedrine Nasal Decongestant, Discount Drug Mart Food Fail Suphedrine Nasal Decongestant, DR duane reade Suphedrine Nasal Decongestant, Family Dollar Suphedrine Nasal Decongestant, Fred's Su-Phedrine Nasal Decongestant, GU Suphedrine Nasal Decongestant, Kinney Brand Suphedrine Nasal Decongestant, Snyder Nasal Decongestant Tablets, Medic Drug Su-Phedrine Nasal Decongestant, MS Pharmaceutical Nasal Decongestant, Smart Choice Suphedrine, Nasal Decongestant, and Equate Suphedrine Nasal Decongestant.

Recall #D-063-1.

CODE
Finast, Super G and Stop & Shop label (American Sales) - 24, 32, 48 & 96 count bottles:
9082936 9104852 9106069 0044035 0055561 0066224
0066694 0GC0388 9034361 9034878 9035045 9057607
9068669 9082079 9094142 0010534 0044034 0GC0117
9035056 9046765 9068515 9129219 8120905 9082207
9128291 9094140 9105257 0019897 0043638 0043786
9094137 9104855 0019404 0019406 0021517 0055205
0055987 0066597 0GC0881 0KC2146 9070335 9070756
9094147 9116552 9127841 0019536 0022101 0066872
0GC0883 9069517 9071128 9104861 0010450 9035138
9046343 9046761 9082311 9094146 9106016 9117038
0032485 0044033 0067330 0GC0118 9023527 9068516
9129216 0GC0116 9129218
Family Pharmacy label (Amerisource) - 24 & 96 count bottles:
9104853 9116778 9117720 9129147 0019448 0019468 0019774 0021516 0032432 0032433 0066596 0GC0389 0GC1215 0HC0687 OKC2326 9034880 9046346 9057119 9058224 9068671 9082158 9082310 9082932 9117435 0019535 0021289 0032548 0GC1217 9046705 9068517 9082148
Medallion label (Ames) - 24 count bottle:
9104850 9106223 9116781 9117592 9128975 0033445 0044031 0055549 0HC0112 OKC1892 0KC2301 9045792
9046344 9046760 9057621 9068664 9069862 9082930 9128975 9069930 9093707
1st Choice label (Bindely Western)- 24 & 48 count bottles:
9082078 9068665 9082078 0033493 0044036 9106224 9128666 0019948 0021103 0022090 0054806 0055648 9056974

Brooks label (Brooks) - 24, 48 & 96 count bottles:
9105258 9117027 0010593 0043788 0055646 0066697
0KC1891 9034884 9046574 9068677 9082080 9129226
9104851 9105847 9116779 9117594 9128667 0010447
0021102 0021514 0033102 0044219 0066308 0067046
0GC0314 9034750 9046345 9070758 9082077 9082307
9082931 9105848 9105849 9105851 9106017 9127842
0019544 0021288 0GC1059 9035141
Demoulas label (Demoulas) - 24 & 48 count bottles:
9105310 9117724 9129156 0010595 0043791 0066836
9035139 9129156 9117154 9129154 0010225 0010449
9046574 9069427 9069499
Discount Drug Mart label (Discount Drug Mart) - 24 & 96 count bottles:
9127962 0019403 0HC0688 9034957 9068668 9070759
0019531 0021975 9035057 9068518
Duane Reade label (Duane Reade)- 24 & 96 count bottles:
0022089 0054892 9057335 0022103 0044571 9057123
0022091
Family Dollar label (Family Dollar) - 24 & 384 count bottles:
9129293 9128996 9128998 9129126 9094404 9094063
9094064 9094065 9094066 9094244 9106070 9106331
9117028 9117096 0010208 0010451 0021974 0032372
0032549 0033097 0033100 0043528 0043783 0044572
0054804 0055422 0066311 0067078 0GC0429 9035050
9045870 9046467 9057125 9057667 9058225 9069859
9070752 9082308
Freds label (Fred's) - 24 count bottle:
9104854 9105615 9106330 0032371 0033422 0043639
0055423 0066310 0067047 0HC0689 0KC2147 0KC2332
9046347 9057620 9070760
Goldline label (Goldline) - 24 count bottle:
9104915 0019318 0019319 9011513 9023646 9056973
9070755
GU label (Grand Union) - 24 count bottle:
9104856 9106328 9117029 0019540 0021104 0043787
0066309 9034881 9058282 9069495 9071585
Kinney Brand label (Kinney Drug) - 24 count bottle:
9106341 9127847 0019469 0032328 0043640 0GC0316
0GC0879 9011669 9057124 9069731
Medic Drug label (Medic Drug) - 24 & 96 count bottle:
9106327 0044573 9068672 9105854
MS Pharmaceutical label (Meyers) - 24 count bottle:
9082934 9104857 9106326 0032370 0MC0275 9046348
9068674 9129220 0KC1893
Smart Choice label (Smart Choice) - 24 count bottle:
9104858 9116776 9117030 9127845 9128669 0010598
0019383 0019541 0019893 0021973 0043641 9035040
9035042 9046764 9060130 9068675 9082157 9082933
Snyder's label (Snyder's) - 24 & 96 count bottle:
9104859 9106325 9117155 9129190 0HC0690 0KC1894
9034372 9035136 9046385 9057033 9068673 9070964
9082309 9105855 9117037 0032700 0044032 9034371
9070699 9071129
Equate label (Wal Mart) - 24 & 96 count bottle:
9071649 9094646 9104849 9106056 9106075 9106440
9106441 9116918 9117252 9117373 9128015 0010174
0010175 0010472 0010749 0019416 0032373 0032547
0043861 0043862 0055507 0055911 0066312 0067395
0GC0390 9023557 9034153 9034576 9034768 9045634
9046349 9046709 9057379 9057666 9070747 9081968
9082312 9093639 9129152 9071278 9071648 9082567
9082619 9082819 9083131 9093544 9094383 9105519
9105783 9105840 9106015 9106324 9106442 9116551
9116691 9117039 9117097 9117405 9127844 9127995
9128236 0010132 0010365 0010366 0010536 0010750
0019530 0019763 0021834 0032544 0032545 0032714
0032715 0043863 0043864 0043865 0044570 0044698
0055283 0055284 0055285 0066184 0066185 0067331
0067332 0GC1218 8121131 9023116 9023404 9033917
9034154 9034507 9034508 9034511 9034834 9034987
9035020 9035264 9045385 9046620 9046622 9068519
9069496 9069953 9070234 9070235 9070236 9070243
9071042 9081967 9093640 9128552 9129125 9129151
Medic W/D label (Winn Dixie) - 24 count bottle:
9104862 9117095 9117359 9127848 9129155 0021105
0032550 0055039 0066696 0GC0317 0KC1896 0KC2120
9045655 9045818 9068676.

MANUFACTURER
Leiner Health Products, Inc., Wilson, North Carolina.

RECALLED BY
Leiner Health Products, Inc., Carson, California, by letter on November 30, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Arkansas, California, Connecticut, Florida, Indiana, Maryland, Massachusetts, Minnesota, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee.

QUANTITY
Volume in commerce:
American Sales - 392,544
Amerisource - 139,680
Ames - 53,016
Bindely Western - 14,400 + 30,891
Brooks - 80,352
Demoulas - 40,320
Discount Drug Mart - 37,440
Duane Reade - 16,848
Family Dollar - 609,112
Freds 70,992
Goldline - 204,192
Grand Union - 29,088
Kinney Drug - 21,888
Medic Drug - 5,760
Meyers - 17,856
Smart Choice - 122,112
Snyders - 40,464
Wal Mart - 6,120,896
Winn Dixie - 92,016.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers December 26, 2000.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

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

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