FEBRUARY 2007
WEEK ENDING FEBRUARY 3
PRODUCT Methotrexate Injection,
USP, (Contains Preservative) 50 mg/2 mL (25 mg/mL), Sterile, Rx drug for I.V.
use only; 2 mL single dose vial; NDC 63323-123-02,
CODE Lot numbers 200653 and 200656, expiration date
6/2007 for both lots
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Abraxis Pharmaceutical Products, Rosemont, IL,
Manufacturer: Abraxis Pharmaceutical Products, Melrose Park, IL,
REASON
Exceeds specification for pH
VOLUME OF
PRODUCT IN COMMERCE 28,482 vials
DISTRIBUTION Nationwide and
Puerto Rico
WEEK ENDING FEBRUARY 10
PRODUCT
Neophase Natural Sex
Enhancer formula for MEN Herbal Supplement, Proprietary Blend 700mg of
Ginsenoside, Rhodiola crenulata root, Lysium chinesis fruit, Curculigo rhizome
root, Licorice root, Snow lotus flower, Cuscuta chinesis and Cordyceps sinensis,
4 Soft capsules per bottle,
CODE All
Codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: North
American Distributor Group, LLC, San Francisco, CA, Manufacturer: Vigor
Nutriceutical, Inc., Sun Prairie,
WI.
REASON Unapproved New Drug;
product found to contain homosildenafil, an analogue of sildenafil.
VOLUME
OF PRODUCT IN COMMERCE 396 bottles
DISTRIBUTION CA
PRODUCT
a) Skin Effects Daily
Anti-Aging Cream with SPF 15, (Octinoxate 7.5%, Oxybenzone 5%), Net Wt. 2 oz
(56g) jars, UPC 0-50428-07901-0,
b) Skin Effects by Dr.
Jeffrey Dover Advanced Brightening Complex, (Hydroquinone) 2%, Net wt. 1oz
(28.4g), UPC 0-50428-07899-0;
c) Skin Effects by Dr.
Jeffrey Dover Complete Lip Care System (Avobenzone 2% and Octinoxate 7.5%),
System includes; Lip Smoothing Scrub Net wt. .49 oz. (14g), Peptide
Treatment Serum Net wt. .08 oz. (2.4g) and Lip Balm SPF 15 Net wt. .08 oz.
(2.3g), UPC 0-500428-08677-3, ;
d) Skin Effects by Dr.
Jeffrey Dover Lightweight Moisturizing Souffle with SPF 30+, (Avobenzone 3%,
Octinoxate 7.5%, and Octisalate 5%), Net wt. 1 oz. (29g) jars, UPC
0-50428-09340-5, Recall # D-428-2007;
e) Skin Effects by Dr. Jeffrey Dover
Redness Control Daily UV Moisturizer SPF 30+, (Octinoxate 7%, Oxybenzone 6%
and Octisalate 5%), Net wt. 1 oz. (29g) jars, UPC 0-50428-09341-2;
f) Skin Effects by Dr. Jeffrey Dover Lightweight Moisturizing
Souffle SPF 30+ for
Sensitive Skin, (Avobenzone 3%, Octinoxate 7.5%, and
Octisalate 5%), Net wt. 1 oz. (29g) jars, UPC 0-50428-09339-9,
CODE
a) Lot Number/EXP Date: FT5 EXP. 0507 F25 EXP 0507
F35 EXP 0607
GG5 EXP0507 GZ5 EXP0607 GY5 EXP0607 HL5 EXP 0607 A05 EXP0607
KD5 EXP0607 BG6 EXP0208 BI6 EXP0208 ED6 EXP0408 EZ6 EXP0408
HY6 EXP0408
JY6 EXP0708;
b) Lot Numbers/EXP Date: FT5 EXP 0607 FX5 EXP 0607 GS5 EXP 0607
GV5 EXP0607 HE5 EXP 0607 LA5 EXP 1107 LE5 EXP 1107 LB5 EXP 1107
LC5 EXP
1107 LF5 EXP1107;
c) Lot Numbers/Exp Date: LOT BG6 EXP 0108 LOT BJ6 EXP 0108
LOT BM6 EXP 0108;
d) Lot Numbers: FG6 EXP 0408 GL6 EXP 0408 J56
EXP1008;
e) Lot Numbers: 6E1 EXP 0508 42734-0 EXP 1008;
f) Lot Numbers;
FI6 EXP 0408 GM6 EXP 0408 J66 EXP 1008
RECALLING
FIRM/MANUFACTURER Diversified Distribution, Woonsocket, RI,
REASON
Labeling; Outer carton fails to include lot number
and expiration.
VOLUME OF PRODUCT IN COMMERCE 129,298
units
DISTRIBUTION Nationwide
PRODUCT Assured Cough Drops
Cherry (Menthol) 7.0 mg, Cough Suppressant and Oral Anesthetic, 50 individually
wrapped drops per bag, 12 bags per case; UPC 6 39277 01822 9,
CODE
Lot numbers A6256, B6256, A6257,
B6257
RECALLING FIRM/MANUFACTURER Primrose Candy Co., Chicago, IL, REASON
Mislabeled; product interior wrapper incorrectly
labeled as "Sugar Free"
VOLUME OF PRODUCT IN COMMERCE 338
cases
DISTRIBUTION GA and WA
PRODUCT Ciprofloxacin Injection,
USP 1200mg (10mg/mL), 120mL vial, Pharmacy Bulk Package, Not For Direct
Infusion, Rx only,
CODE Lot 1161864, expiration
date 10/08.
RECALLING FIRM/MANUFACTURER Ben Venue Laboratories,
Inc., Bedford, OH,
REASON Mislabeled; carton and vial label incorrectly
states 12 g per 120 mL sterile 1% solution, but should correctly state 1.2 g per
120 mL sterile 1% solution.
VOLUME OF PRODUCT IN COMMERCE 903
vials
DISTRIBUTION Nationwide
PRODUCT
a)
Bacitraycin Plus with Moisturizing Aloe First Aid Ointment,
(Bacitracin, 500
units), 1.0 oz. (28 g) tube,
b) Bacitraycin Plus with
Moisturizing Aloe Maximum Strength First Aid Ointment,
(Bacitracin, 500
units, Pramoxine HCl 10mg), 1.0 oz. (28 g) tube,
CODE
a) Lot Numbers: 60126E1208, 60127E1208, 60130
E1208;
b) Lot numbers 60314E0108, 60315E0108
RECALLING
FIRM/MANUFACTURER Sheffied Laboratories, Div., of Faria Limited LLC, New
London, CT
REASON Product stability may not
be assured to expiration.
VOLUME OF PRODUCT IN COMMERCE 102,288
tubes
DISTRIBUTION NY
WEEK ENDING FEBRUARY 17
PRODUCT NASUTRA Herbal
Supplement for Men, proprietary blend of ten chinese herbs, 300mg, packaged in
blisters of 2 capsules,
CODE Lot #: WP-505, WP904,
WP1005, WP106, WP206, WPNA5O6 & WPNA7O6
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Nasutra LLC, Beverly Hills, CA,
Manufacturer:
Bactolac Pharmaceutical, Inc., Hauppauge, NY.
REASON Unapproved New Drug; Product contains undeclared acetildenafil, an analogue of
sildenafil.
VOLUME OF PRODUCT IN
COMMERCE 1,105,000 X 2-capsule units
DISTRIBUTION Nationwide
and via the Internet
PRODUCT TYGACIL (tigecycline) for Injection - 50mg per vial 10 single use vials, Rx only, Each
vial contains 50mg tigecycline lyophilized powder for intravenous infusion -
Wyeth Pharmaceuticals, Inc. NDC: 0008-5360-02,
CODE Lot # B67262 and Lot # B67263
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories,
Philadelphia, PA,
Manufacturer:
Patheon Italia S.p.A., Milano, Italy.
REASON Discolored solution upon
reconstitution.
VOLUME OF PRODUCT IN COMMERCE 7,458
units
DISTRIBUTION Nationwide, Venezuela and Chile
PRODUCT Compressed Gas,
Oxidizing, N.O.S., Medical Gas Mixtures, UN 3156, 20% Carbon Dioxide, 80%
Oxygen, Size 44 Steel Cylinders,
CODE Lot:
0826BG06
RECALLING FIRM/MANUFACTURER Specialty Gases of America Inc.
Toledo, OH,
REASON Product was fitted with incorrect CGA valve
connection. Correct valve is CGA 500, but product was fitted with CGA
280.
VOLUME OF PRODUCT IN COMMERCE 3
cylinders
DISTRIBUTION MI
PRODUCT SystaneŽ free
Lubricant Eye Drops Liquid Gel, (polyethylene glycol 400, 0.4% and polyethylene
glycol 0.3%), 3mL (sample size) and 10mL, Sterile, CODE 3mL 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
RECALLING
FIRM/MANUFACTURER Alcon Laboratories, Inc. Fort Worth, TX,
REASON
Mold Contamination (Curvularia sp and Alternaria
sp)
VOLUME OF PRODUCT IN COMMERCE 4,191,451
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Loratadine Syrup,
Loratadine Oral Solution USP, 5mg/5mL, 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,
CODE
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
RECALLING
FIRM/MANUFACTURER Ohm Laboratories, Inc., Gloversville, NY
REASON Exceeded impurity specification
VOLUME OF
PRODUCT IN COMMERCE 1,300,750
bottles
DISTRIBUTION Nationwide and PR
WEEK ENDING FEBRUARY 24
PRODUCT Alesse-28 Tablets
Clinical Packs, levonorgestral 0.10mg and ethinyl estradiol 0.02mg, 28 tablet
blister packs, 50 count box, NDC 0008-2576-03, CODE Lots # A66651 (Exp 12/06) and A66652 (Exp.
1/07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth
Ayerst Laboratories, Philadelphia, PA,
Manufacturer: Wyeth Pharmaceuticals Company,
Guayama, PR.
REASON Impurity (18 month
stability)
VOLUME OF PRODUCT IN COMMERCE 9,032 (50 blister
packs)
DISTRIBUTION Nationwide
PRODUCT GlipiZIDE 5mg
Tablets USP, 100 count Unit Dose packages and 100 count bottles, NDC
0182-1994-89 and NDC 0172-3649-60,
CODE Lot #
138020A Exp. Date 02/2007 Lot #138020U, Exp. Date 02/2007
RECALLING
FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL,
Manufacturer: Ivax Pharmaceuticals,
Inc., Cidra, PR.
REASON Exceeds
Impurity Specification
VOLUME OF PRODUCT IN COMMERCE 13,848 bottles
and 6,024 UD
DISTRIBUTION Nationwide and PR
PRODUCT Control Rx 5000 ppm
Fluoride Prescription Dentrifice, Berry Flavor, 2 oz. (56 g). RX, Omnii, NDC
48878-3101-6,
CODE Lot Numbers: 60407E03/08
60410E03/08
RECALLING FIRM/MANUFACTURER Sheffield Laboratories,
Div. of Faria Limited LLC, New London, CT,
REASON Superpotent
(fluoride)
VOLUME OF PRODUCT IN COMMERCE 25,776
tubes
DISTRIBUTION FL