Chart: FDA Recalls & Court Actions

FDA Recalls & Court Actions		Feb. 14, 2007
CLASS I
Nasutra Herbal Supplement for Men
Proprietary blend of 10 Chinese herbs, 300 mg, packaged in blisters of 2 capsules, Lot #: WP-505, WP904, WP1005, WP106, WP206, WPNA5O6 & WPNA7O6.
Manufacturer:	Bactolac Pharmaceutical, Inc., Hauppauge, NY.
Recalled by:	Nasutra LLC, Beverly Hills, CA, by letter and press release on Sept. 20, 2006. Firm-initiated recall is ongoing.
Distribution:	Nationwide and via the Internet; 1,105,000 X 2-capsule units.
Reason:	Unapproved New Drug; Product contains undeclared acetildenafil, an analogue of sildenafil.
Recall number:	D-438-7.
CLASS II
Systane Free Lubricant Eye Drops Liquid Gel
Polyethylene glycol 400, 0.4% and polyethylene glycol 0.3%, 3 mL (sample size) and 10 mL, sterile, 3 mL size lot codes: 63722F, 114115F, 60907F, 63239F, 121916F, 120742F, 122349F, 114984F, 120081F, and 121936F; 10mL size lot codes: 63190F, 61410F, 113575F, 113576F, 115267F, 115809F, 115808F, and 115268F.
Manufacturer:	Alcon Laboratories, Inc., Fort Worth, TX.
Recalled by:	Manufacturer, by press release on Dec. 14, 2006 and by letters on Dec. 15, 2006. Firm-initiated recall is ongoing.
Distribution:	Nationwide and internationally; 4,191,451 units.
Reason:	Mold Contamination (Curvularia sp and Alternaria sp).
Recall number:	D-442-7.
CLASS III
Loratadine Syrup
Loratadine oral solution USP, 5 mg/5 mL, Fruit Flavored Syrup, 4 oz. and 8 oz. bottles, NDC 51660-207-04 (4 oz. Ohm label) and NDC 51660-207-08 (8 oz. Ohm label), OTC --- The product was distributed under the following labels and NDC #s: (1) AMERICAN FARE for kids LORATADINE ORAL SOLUTION 5mg/5mL Loratadine Syrup, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (120 mL), NDC 49738-207-04, Made for Kmart Corporation, Troy, MI; (2) BROOKS/ECKERD Children's Allergy Relief LORATADINE SYRUP (LORATADINE ORAL SOLUTION) 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), ITEM# 024540, Distributed By: Brooks/Eckerd Pharmacy Warwick, RI; (3) CVS pharmacy CHILDREN'S ALLERGY RELIEF LORATADINE ORAL SOLUTION 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI; (4) ECKERD Children's Allergy Relief LORATADINE SYRUP (LORATADINE ORAL SOLUTION) 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 19458-9403-1, DISTRIBUTED BY: ECKERD DRUG COMPANY CLEARWATER, FL; (5) Best Choice Brand Children's Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO. KANSAS CITY, MO; (6) Kroger Children's Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 30142-649-26, Distributed by The Kroger Co. Cincinnati, OH; (7) LEADER Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine for kids, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 37205-378-26, DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OH; (8) MEDIC Children's Allergy FRUIT FLAVORED SYRUP Loratadine Oral Solution 5mg/5mL Antihistamine, 4 FL OZ (118 mL), NDC 56039-207-04, Distributed By: Winn-Dixie Stores, Inc. Jacksonville, FL; (9) ohm Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL Antihistamine, Children's Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 51660-207-04, Manufactured by: Ohm Laboratories, Inc., Gloversville, NY; (10) ohm Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Children's Fruit Flavored Syrup, 8 FL OZ (236 mL), NDC 51660-207-08, Manufactured By: Ohm Laboratories, Inc. Gloversville, NY; (11) QC QUALITY CHOICE Children's Allergy Relief Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 63868-156-04, DISTRIBUTED BY QUALITY CHOICE NOVI, MI; (12) RITE AID Children's Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), DISTRIBUTED BY RITE AID CORPORATION HARRISBURG, PA; (13) select brand Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Children's Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 15127-718-04, Distributed by: SELECT BRAND DISTRIBUTORS Pine Bluff, AR; (14) select brand Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Children's Fruit Flavored Syrup, 8 FL OZ (236 mL), NDC 15127-715-08, Distributed by: SELECT BRAND DISTRIBUTORS Pine Bluff, AR; (15) The Medicine Shoppe Allergy Relief for kids Loratadine Oral Solution 5mg/5mL, Antihistamine, FRUIT FLAVORED SYRUP, 4 FL OZ (118 mL), NDC 49614-174-26, Distributed by: Medicine Shoppe International, Inc. St. Louis, MO; (16) Walgreens Children's Wal-itin Loratadine Oral Solution 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 0363-207-04, Distributed by: Walgreen Co., Deerfield, IL, Lots in total: 1428192, 1431263, 1431837, 1440256, 1443259, 1446539, 1447175, 1447176, 1449358, 1453992, 1453995, 1458852, 1461269, 1465392, 1465393, 1466839, 1466840, 1468243, 1471544, 1472957, 1476246, 1477061, 1477062, 1477085, 1477801, 1477802, 1477803, 1477804, 1477806, 1479489, 1479490, 1481287, 1481288, 1481289, 1481294, 1483852, 1483853, 1483854, 1485685, 1485686, 1486071, 1486072, 1487152, 1487154, 1487155, 1487156, 1487157, 1490488, 1491237, 1491731, 1491732, 1492190, 1492191, 1497045, 1498061, 1500107, 1500108, 1508797, 1508798, 1512236, 1512237, 1517700, 1519980, 1519982, 1519984, 1519985, 1520009, 1529147, 1529148, 1531453, 1531454, 1532134, 1534046, 1534072, 1534073, 1535554, 1535555, 1537063, 1537065, 1537066, 1537067, 1537068, 1541069, 1541071, 1543580, 1543581, 1543582, 1543583, 1548242, 1548244, 1549504, 1549505, 1549506, 1549507, 1551442, 1551789, 1551791, 1551792, 1558368, 1558369, 1558370, 1558371, 1562461, 1568759, 1568760, 1576980, 1576981, 1585284, 1586606, 1586615, 1586616, 1586617, 1586619, 1599029, 1599030, 1599031, 1599032, 1599033, 1608385, 1608386, 1612443, 1612444, 1612445, 1621602, 1621629, 1621630, 1621631, 1621632, 1621633, 1626627, 1626628, 1626629, 1630200, 1637979, 1639172, 1639173, 1639175, 1644206, 1644207, 1647251, 1647252, 1647253, 1649825, 1649826, 1649827, 1658678, 1658679, 1660927, 1660928, 1665178, 1665179, 1665180, 1669064, 1669065, 1673431, 1673432, 1673433.
Manufacturer:	Ohm Laboratories, Inc., Gloversville, NY.
Recalled by:	Manufacturer, by letters dated Jan. 3, 2007. Firm-initiated recall is ongoing.
Distribution:	Nationwide and PR; 1,300,750 bottles.
Reason:	Exceeded impurity specification.
Recall number:	D-0439-7.
EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Tan Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation.