DECEMBER 2000

WEEK ENDING DECEMBER 1

PRODUCT Touro brand Rx (cough and cold; allergy), in unit dose packages of physician samples as follows:
a) TOURO ALLERGY Capsule, (Brompheniramine Maleate 5.75 mg and Pseudoephedrine 60 mg), Physician sample,
b) TOURO CC Caplets, (Dextromethorphan hydrobromide 30 mg, Pseudoephrine 60 mg and Guaifensin 575 mg), Physician sample,
c) TOURO DM Caplets, (Dextromethorphan hydrobromide 30 mg and Guaifensin 575 mg), Physician sample,
d) TOURO EX Caplets, (Guaifensin 575 mg), Physician sample,
e) TOURO LA Caplets, (Pseudoephrine HCL 120 mg and Guaifensin 575 mg), Physician sample.
CODE LOT Numbers: a) 419; b) 772; c) 471; d) 394C01; e) 699.
MANUFACTURER PharmaFab, Grand Prairie, Texas.
RECALLED BY Darthmouth Pharmaceuticals, Inc., Wareham, Massachusetts (repacker)
DISTRIBUTION Connecticut, Massachusetts, Rhode Island.
QUANTITY The amount of product in commerce is approximately as follows:
Touro Allergy 966 boxes of 30 UDPs;
Touro CC 1004 boxes of 30 UDPs;
Touro DM 888 boxes of 30 UDPs;
Touro EX 546 boxes of 30 UDPs;
Touro LA 670 boxes of 30 UDPs.
REASON Lack of data to support labeled expiration date.

PRODUCT ALLERx(tm) Tablets, Pseudoephedrine HCL 120 mg, Methscopolamine Nitrate 2.5 mg, Chlorpheniramine Maleate 8 mg), 10 day trade pack, Rx.
CODE Lot #0G06701.
MANUFACTURER Adams Laboratories, Inc., Fort Worth, exas.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 7,678 individual units were distributed; firm estimated that less than 5 percent of product remained on market at time of recall initiation.
REASON Tablets in reverse order for AM and PM dispensing.

GLAXO WELLCOME TO WITHDRAW LOTRONEX

Glaxo Wellcome, of Research Triangle Park, NC, has informed FDA that it will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from the market. Lotronex is a prescription medication approved to treat Irritable Bowel Syndrome(IBS) in women. The FDA is advising patients taking Lotronex to contact their healthcare providers to discuss treatment alternatives.

Today’s action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5 reports of death in patients taking Lotronex. Specifically, FDA has been concerned about reported cases of intestinal damage resulting from reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severe constipation).

As of November 10, 2000, FDA had received and reviewed a total of 70 cases of serious post-marketing adverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation. Of the 70 cases, 34 resulted in hospitalization without surgery, 10 resulted in surgical procedures, and three resulted in death. FDA has received two additional reports of death that the agency did not classify as being cases of ischemic colitis or severe complications of constipation. FDA continued to receive severe adverse event reports of ischemic colitis and complications of constipation associated with Lotronex. In addition, FDA received reports of death and more serious complications of ischemic colitis that required blood transfusion or surgery.

WEEK ENDING DECEMBER 8

PRODUCT Glyburide Tablets, USP (micronized), Rx, indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-deptendent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone:
(a) Glyburide Tablets, 6 mg, in 100-count bottles
(b) Glyburide Tablets, 1.5 mg, in 100-count bottles
CODE Lot Numbers: a) ST 43001A EXP 3/01; b) TT 2411A EXP 11/00.
MANUFACTURER MOVA Pharmaceuticals Corporation, Caguas, Puerto Rico.
DISTRIBUTION Nationwide.
QUANTITY 10,615 bottles were distributed.
REASON a) Blend uniformity non-conformance with RSD specification. b) Subpotency.

PRODUCT Prednisone 5 mg Tablets, USP, in 100 and 1000-count bottles, 12 bottles per innerpack, and 12 innerpacks per carton, sold under the Mutual label in 1000-count bottles (NDC #53489-138-10), and the URL label in 100-count bottles intended for endocrine disorders, rheumatic disorders, collagen diseases, dermatological diseases, allergic states, ophthalmic diseases, respiratory diseases, hematological disorders, neoplastic diseases, edematous states, and gastrointestinal diseases.
CODE Lot Numbers: 42129 EXP 12/02 and 42130 EXP 12/02.
MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY 3,857 100-tablet bottless and 6,391 1000-tablet bottles. Firm estimated that 10% of the recalled lots remained on market at time of recall initiation.
REASON Blend uniformity failure.

PRODUCT Prednisone Tablets, 5 mg, in 1-tablet blister packages, Rx oral glucocorticoid adrenocortical steroid used in the treatment of primary or secondary adrenocortical insufficiency.
CODE Lot #OH568 EXP 5/02.
MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia, Pennsylvania.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker)
DISTRIBUTION Nationwide.
QUANTITY 4,076 unit cartons of 25 tablets each were distributed; firm estimated that 30% of the products remained on the market at time of recall initiation.
REASON Blend uniformity failure.

PRODUCT Prescription Conjugated Estrogen Tablets:
a) Premarin (conjugated estrogens tablets), 0.625 mg, in 100-tablet bottles; 1000-tablet bottles; 5000-tablet bottles
b) Premarin (conjugated estrogens tablets), 0.9 mg, in 100-tablet bottles
c) Premarin (conjugated estrogens tablets), 1.25 mg, in 5000-tablet bottles
d) Premarin (conjugated estrogens tablets), 2.5 mg, in 100-tablet bottles; 1000-tablet bottles
e) Premphase 0.625 mg/5 mg tablets (conjugated estrogens/ Medroxyprogesterone acetate), in EZ-dial dispensers
CODE a) 100-tablet bottle Lot #s: 9990085, 9990358, 9990583, and 9990584, EXP dates: September 2002 through December 2003; 1000-tablet bottle Lot #s: 9980880, 9990086 EXP Dates: September 2002 and January 2003;5000-tablet bottle Lot #s: 9980299, 9981799, 9990290, 9990297, 9990298, and 9990585 EXP Dates: September 2002 through December 2003;
b) 100-tablet bottle Lot #s: 9980266, 9980282, 9980649, 9980869, 9981043, 9981044, 9981200, 9981201, 9981497, 9981585, 9981730, 9990074, 9990075, 9990173, 9990174, 9990279, 9990280, 9990281, 9990403, 9990404, 9990405, 9990569, 9990570, 9990571, 9990572, 9990705, 9990958, 9990959,
9990960, 9991012, 9991017, 9991165, 9991283, 9991377 EXP Dates: September 2002 through April 2004;
c) 5000-tablet bottle Lot #9980874, EXP February 2003;
d) 100-tablet bottle Lot #9990282 EXP October 2003; 1000-tablet bottle Lot #s: 9990175 and 9990283 EXP Dates: October 2003;
e) EZ Dial Dispenser: Lot #9990235, EXP June 2001.
MANUFACTURER (Responsible Firm) Ayerst Laboratories, Division of Wyeth-Ayerst Pharmaceuticals, Inc., Rouses Point, New York, and Wyeth Pharmaceuticals Company, Guayma, Puerto Rico.
RECALLED BY Wyeth-Ayerst Laboratories, Richmond, Virginia
DISTRIBUTION Nationwide and Malta.
QUANTITY a) 154,977 100-tablet bottles, 27,351 1000-tablet bottles, and 16,348 5000-tablet bottles; b) 2,393,436 100-tablet bottles;
c) 2,378 5000-tablet bottles; d) 8,304 100-tablet bottles and 6,256 1000-tablet bottles; e) 41,220 units were distributed.
REASON Dissolution Failure.

PRODUCT Conjugated estrogen tablets, Rx, repackaged in bottles as follows: a) Premarin(r) Tablets (conjugated estrogens tablets), 0.625 mg, 100-count & 1,000-count
b) Premarin(r) Tablets (conjugated estrogens tablets), 0.9mg, 90-count bottles.
c) Premarin(r) Tablets (conjugated estrogens tablets), 1.25mg, 100-count bottles
d) Premarin(r) Tablets (conjugated estrogens tablets), 2.5mg, 100-count bottles.
CODE Lot Numbers: 8086 EXP 8/6/00; 8482 EXP 9/25/00; 8898 EXP 11/10/00; 8923, EXP 11/13/00; 11210A, EXP 6/28/01; 11210B EXP 7/9/01; 11210C EXP 7/20/01; 11492A EXP 8/10/01; 11492B EXP 8/30/01; 11935 EXP 9/29/01; 12336 EXP 11/16/01; 12878 EXP 2/25/02; 13496 EXP 1/17/02.
MANUFACTURER Wyeth-Ayerst Laboratories, Rouses, New York.
RECALLED BY AmeriSource Health Services Corporation, doing business as American Health Packaging (AHP) (relabeler/repacker/ distributor)
DISTRIBUTION Nationwide.
QUANTITY 14,785 bottles were distributed.
REASON Manufacturer's dissolution failure.

PRODUCT Desoximetasone Ointment, USP, 0.25%, in 15 and 60-gram tubes, Rx topical corticosteroid ointment, (15g) and (60g).
CODE Lot #D756 EXP 11/00.
MANUFACTURER Altanta, Inc., Hicksville, New York.
RECALLED BY Altana, Inc., Melville, New York
DISTRIBUTION Nationwide.
QUANTITY 2,130 15-gram and 2,135 60-gram tubes were distributed; firm estimated that little or no product remained on market at time of recall initiation.
REASON Degradation failure at 12-month stability testing.

WEEK ENDING DECEMBER 15

PRODUCT a) Synthroid(r) tablets (Levothyroxine sodium tablets, USP) 112 mcg (0.112mg); b) Synthroid(r) tablets (Levothyroxine sodium tablets, USP), 200 mcg (0.2mg).
CODE a) Lot #00045501, physician samples, 4 cards of 7 tablets; b) Lot #00045517, physician samples, 4 cards of 7 tablets.
MANUFACTURER Knoll Pharmaceuticals, Jayuya, Puerto Rico.
RECALLED BY Knoll Pharmaceutical Company, Mount Olive, New Jersey
DISTRIBUTION Undetermined.
QUANTITY a) 17,476 (boxes of 4 cards); b) 12,998 (boxes of 4 cards) were distributed.
REASON Mis-packaging - 100 mcg product was packaged into 200 mcg card.

PRODUCT Skin Guardian, in 2-ounce aerosol cans, OTC topical skin protectant.
CODE Any code shipped after 6/28/00.
MANUFACTURER Unique Laboratories, Inc., Chatsworth, Georgia.
DISTRIBUTION Oklahoma.
QUANTITY 110 cases (24 units per case) were distributed.
REASON Product is an unapproved new drug.

PRODUCT Ibuprofen Tablets, USP, 400 mg, in blister packs 10 x 10 tablets, Rx oral non-steroidal anti-inflammatory agent.
CODE Lot #21392 EXP 12/01.
MANUFACTURER BASF Corporation, Shreveport, Louisiana.
RECALLED BY Watson Pharmaceutical, Inc., (formerly Schein Pharmaceutical, Inc.), Florham Park, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 5,809 cartons were distributed; firm estimated that less than 5 percent of product remained on market at time of recall initiation.
REASON Dissolution failure (3-month stability).

PRODUCT Triaminic(r) Vapor Patch(tm) Menthol Scent, Cough Suppressant, (Camphor 4.7%/Menthol 2.6%) in boxes of 6 patches, OTC for the treatment of cough.
CODE Lot Numbers: LE505342 EXP 6/02, LE505483 EXP 6/02, LE505503 EXP 7/02, LE505536 EXP 7/02, LE505588 EXP 7/02, LE505680 EXP 8/02.
MANUFACTURER Lectec Corporation, Minnetonka, Minnesota.
RECALLED BY Novartis Consumer Health, Inc., Summit, New Jersey
DISTRIBUTION Nationwide.
QUANTITY Approximately 56,544 cartons of lot LE505342; 50,040 cartons of lot LE505483; 53,928 cartons of lot LE505503, 42,720 cartons of lot LE505536; 5,856 cartons of lot LE505588; 14,328 cartons of lot LE505680 were distributed.
REASON Pouch seal failures (opening along top, sides and/or bottom).

WEEK ENDING DECEMBER 22

PRODUCT Etodolac Capsules (Lodine Capsules), 300 mg, in 100-unit bottles, Rx used for arthritis and pain management.
CODE Lot #9991052 EXP 7/02.
MANUFACTURER Wyeth-Ayerst Company, Guayama, Puerto Rico.
RECALLED BY Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY Approximately 935 units were distributed.
REASON Cross contamination with Acebutolol Hydrochloride, a beta-blocker drug.

WEEK ENDING DECEMBER 29
 

PRODUCT Tegretol(r) (carbamazepine), 200 mg, in 100 and 1,000 unit bottles, Rx product indicated for use as an anticonvulsant associated with epilepsy.

CODE Lot Numbers: 128B1120 EXP 6/02, 156B3063 EXP 10/02, 158B3063 EXP 10/02, 170D4247 EXP 1/03, 121B9991 EXP 4/02, 137B1238 EXP 6/02, 144B1825 EXP 8/02, 150B2289 EXP 1/02, 155B2289 EXP 10/02, and 1T237018 EXP 9/01.

MANUFACTURER Novartis Pharmaceutical Corporation, Suffern, New York.

DISTRIBUTION Nationwide.

QUANTITY 150,223 bottles to 100’s and 22,363 bottles of 1000’s were distributed.

REASON Dissolution failure.

PRODUCT Phenazopyridine Hydrochloride Tablets, USP, 100 mg, in 100-count bottles, Rx for the symptomatic relief of pain burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa.

CODE Lot #046060.

MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

DISTRIBUTION Alabama.

QUANTITY 16,987 units were distributed.

REASON Dissolution failure.

PRODUCT Premarin(r) Tablets, 2.5 mg (Conjugated Estrogen Tablets, USP), in 100-count bottles

CODE Lot Numbers: R9K00522 EXP 08/01, R9K00522A EXP 08/01, R9K00608 EXP 09/01, R9K00608A 09/01.

MANUFACTURER Ayerst Laboratories, Division of Wyeth-Ayerst Pharmaceuticals, Inc., Rouses Point, New York; and Wyeth Pharmaceuticals, Company, Guayama, Puerto Rico.

RECALLED BY Bergen Brunswig Corporation, Orange, California

DISTRIBUTION Nationwide and Puerto Rico.

QUANTITY 5,086 100-tablet bottles were distributed.

REASON Dissolution failure by manufacturer (Wyeth Ayerst).

PRODUCT Triple Sulfa Vaginal Cream, USP (Sulfathiazole/Sulfacetamide/Sulfabenzamide), in 2.75-ounce tube, Rx under the Alpharma label.

CODE Lot #L908034 EXP 2/01.

MANUFACTURER Alpharma USPD, Inc., Lincolnton, North Carolina.

DISTRIBUTION Nationwide, Puerto Rico, Canada.

QUANTITY 37,265 units were distributed.

REASON Subpotency of sulfacetamide at 12 month stability testing.

PRODUCT Suphedrine Cold & Allergy Tablets (Pseudoephedrine HCl 60 mg & Chlorpheniramine Maleate 4 mg), in 24-tablet units, OTC.

CODE Lot #0032996.

MANUFACTURER Leiner Health Products, Wilson, North Carolina.

RECALLED BY Leiner Health Products, Carson, California

DISTRIBUTION Arkansas.

QUANTITY 1,147,392 tablets were distributed.

REASON Failure to manufacture as per validated method -- (reduced blend time and excessive ingredient amount).

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.

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

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.

REASON Failure to validate manufacturing process (sequence of addition of components.