DECEMBER 2005
WEEK ENDING DECEMBER 3
PRODUCT Product is 1-ounce glass
eye dropper bottles of Eye Food. Product is labeled in part: The Old Path “God’s
Herbal Blessing Tea Eye Food: God’s Blessing to Mankind”
CODE All codes are being recalled
RECALLING
FIRM/MANUFACTURER The Old Path Natural Herbs, Inc., Pensacola, FL
REASON
Non-Sterility: The product was contaminated with
multiple strains of bacteria and could cause eye infections and possible
blindness.
VOLUME OF PRODUCT IN COMMERCE 30 1-ounce
bottles
DISTRIBUTION FL, GA, and CA
PRODUCT Cervical Amino Acid
Cream (Urea, Methionine, Inositol, Cystine), Net Wt. 2.75 oz (78 grams), Active
Ingredients: Urea 8.34%, Methionine 0.83%, Inositol 0.83%, Cystine 0.35%
Buffered to pH of 5.5 in a water-miscible cream base, Rx Only, NDC 0603-7729-86
CODE
Lot No. 40719, exp. 05/06; Lot No. 40720, exp
05/06; Lot No. 41008, exp. 07/06; Lot No. 50609, exp. 04/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Qualitest Pharmaceuticals, Inc.,
Huntsville, AL,
Manufacturer:
Sheffield Laboratories, Div. of Faria Limited LLC, New London, CT.
REASON
Method validation deviations
for finished product testing.
VOLUME OF PRODUCT IN COMMERCE 25,395
units
DISTRIBUTION Nationwide and PR
PRODUCT Papain-Urea-Chorophyllin
Ointment, Contains Papain, USP (not less than 521,700 USP units per gram of
ointment), Urea, USP 10% and Chlorophyllin Copper Complex Sodium, USP 0.5% in an
ointment base, Net Wt. 1.1oz (30g), Rx only,. NDC 60258-031-30
CODE Lot no. 30314, exp 02-2006; Lot no. 31216, exp
11-2005, Lot No. 40701, exp 05-2006
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cypress Pharmaceutical, Inc,
Madison, MS
Manufacturer: Sheffield
Laboratories, New London, CT.
REASON Method validation deviations for finished product
testing.
VOLUME OF PRODUCT IN COMMERCE 69,696
units
DISTRIBUTION Nationwide
PRODUCT Ciprofloxacin Ophthalmic
Solution, USP, 0.3%, ciprofloxacin hydrochloride 3.5 mg equivalent to 3 mg base;
Rx only, sterile ophthalmic solution for topical ophthalmic use only in 5 mL
plastic dispenser bottle, 10 bottles per shelf pack, NDC 60505-1000-1
CODE
Lot numbers GP1019, GP2332, GP2334
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Lincolnshire, IL
Manufacturer: Apotex Inc., Ontario,
Canada.
REASON Degradation
Products: Degradation level exceeds specification requirement of less than 0.2%
impurities.
VOLUME OF PRODUCT IN COMMERCE 126,790
units
DISTRIBUTION Nationwide
PRODUCT
a) Aspirin tablets, 325
mg in bottles of 300 and 500, OTC, packaged under the following labels: CVS
Pharmacy brand Dist. by CVS Pharmacy, Inc., Woonsocket, FL; equaline
brand Dist. by Albertsons Inc., Boise, ID NDC 41163-416-87; equate brand
Dist. by Wal-Mart Stores, Inc., Bentonville, AR NDC 49035-416-87 and
49035-416-90; Medic brand Dist. by Winn-Dixie Stores, Inc., Jacksonville, FL NDC 56039-416-87; Meijer brand Dist.
by Meijer Dist.,
Inc., Grand Rapids, MI NDC 41250-416-90; ShopRite brand Dist. by Wakefern
Food Corp., Elizabethtown, NJ and sunmark brand Dist. by
McKesson, San
Francisco, CA, NDC 49348-001-14,
b) Ibuprofen tablets,
200 mg in 100 tablet bottles, OTC, packaged under the following labels:
equate brand
Dist. by Wal-Mart Stores, Inc., Bentonville, AR NDC
49035-604-78; Kroger brand Dist. by The Kroger Co, Cincinnati, OH NDC
30142-604-78 and Meijer brand Dist. by Meijer Dist., Inc, Grand Rapids, MI
NDC 41250-604-78,
CODE
a) Lot numbers: 5JE0024
and 5JE0074;
b) Lot number: 5HE0342
RECALLING
FIRM/MANUFACTURER Perrigo Company, Allegan, MI
REASON Microbial
contamination of a non-sterile product.
VOLUME OF PRODUCT IN
COMMERCE 107,182 bottles
DISTRIBUTION Nationwide
PRODUCT
DG Guarantee, Regular
Strength, Fast Acting Antacid Liquid, Antigas/Antacid original, 12 fl oz
(355mL), OTC
CODE Lot Numbers: CAR 019A, exp
05/07; CAR019B, exp 05/07; CAR020C, exp 05/07; CAR021, exp 05/07; CAR023A, exp
05/07;
RECALLING FIRM/MANUFACTURER ANIP Acquisition Company,
Gulfport, MS
REASON Mislabeling: The package
contained an incorrect rear label which indicates the presence of benzyl
alcohol.
VOLUME OF PRODUCT IN COMMERCE 3,444 cases of 12
units
DISTRIBUTION Nationwide
PRODUCT
a) Robitussin® Cough
& Cold CF Syrup, Cough Suppressant/Expectorant/Nasal Decongestant, (in
each 5 mL tsp) Dextromethorphan HBr USP 10 mg, Guaifenesin USP 100 mg,
and Pseudoephedrine HCl USP 30 mg, 12 FL OZ (355 mL) plastic bottles with
tamper-evident bottle cap and plastic dosage cup per carton and labeled
in part, NDC 0031-8678-30,
b) Robitussin® Cough &
Congestion Syrup, Cough Suppressant/Expectorant, (in each 5mL tsp) Dextromethorphan HBr USP 10 mg and Guaifenesin
USP 200 mg, 4 FL OZ
plastic bottles with tamper-
evident bottle cap and plastic dosage cup per
carton, NDC 0031-8662-12
CODE
a) Lot B07738,
EXP 8/2008;
b) Lot B07708, EXP 8/2008
RECALLING
FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA
REASON Defective Tamper-Evident Closure.
VOLUME OF
PRODUCT IN COMMERCE 5,472
bottles
DISTRIBUTION Nationwide
PRODUCT
a) Bisoprolol Fumarate
Tablets 5 mg, 30 and 100 count bottles, Rx only, NDC 53489-555-07 and
53489-555-01
b) Bisoprolol Fumarate Tablets 10 mg, 30
and 100 count bottles, Rx only, NDC 53489-556-07 and 53489-556-01,
CODE
a) Lot numbers: 51500 exp. 2/06, 51504 exp. 2/06,
52541 exp.6/06, 52728 exp. 7/06, and 53155 exp. 7/06;
b) Lot numbers:
49731 exp. 10/05, 49732 exp. 10/05, 51248 exp. 2/06, 52542 exp. 6/06, 52729
exp. 7/06, 52730 exp. 9/06, and 53128 exp. 9/06
RECALLING
FIRM/MANUFACTURER Mutual Pharmaceutical Co., Inc., Philadelphia, PA
REASON
Exceeds impurity specification.
VOLUME OF
PRODUCT IN COMMERCE 100,118 bottles
DISTRIBUTION Nationwide
and PR
WEEK ENDING DECEMBER 10
PRODUCT Furosemide Tablets, USP,
20 mg, 1000 tablets (white) bottles, NDC 0172-2908-80
CODE Lot 136081 exp 3/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, Inc.,
Northvale, NJ
Manufacturer: IVAX
Pharmaceuticals, Inc., Miami, FL.
REASON Adulterated; presence of foreign tablet
(Labetolol
Tablet 300 mg)
VOLUME OF PRODUCT IN COMMERCE 11,635
bottles
DISTRIBUTION Nationwide
PRODUCT Potassium Acetate
Injection, USP, Concentrated, 200 mEq (4mEq/mL); 50 mL single dose vials, 25
vials per tray; Rx only, Sterile, For IV Use Only After Dilution
CODE
Lot 141218, exp. 3/06
RECALLING
FIRM/MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park,
IL, REASON Exceeds specification for Aluminum content (12
month stability)
VOLUME OF PRODUCT IN COMMERCE 6, 300
vials
DISTRIBUTION Nationwide, Canada, and Hong Kong
PRODUCT Pin-X Liquid, Pyrantel
Pamoate (Pyrantel base 50mg/mL), 2 fl oz (60mL) bottles, Pinworm Treatment, Over
The Counter, NDC 55806-024-11
CODE Lot # 048G04A,
exp 07/06
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC,
Huntsville, AL
REASON USP Antimicrobial Effectiveness Failure (12 month
stability).
VOLUME OF PRODUCT IN COMMERCE 4,896
units
DISTRIBUTION Nationwide
PRODUCT
a) Retin-A Cream (tretinoin) 0.05% tube,
45g and 20g. Supplied in aluminum tubes.
OrthoNeutrogena distributes the branded product and under the Retin-A
Brand description
while the non-branded product is distributed by Clay
Park (Perrigo) as Tretinoin Cream, Rx only,
b) Retin-A
Cream (tretinoin) 0.025% tube, 45g and 20g. Supplied in aluminum
tubes. OrthoNeutrogena distributes the branded product and under the Retin-A Brand
description while the non-branded product
is distributed
by Clay Park (Perrigo) as Tretinoin Cream, Rx only
CODE
a) Lot 5HM496, exp. 07/07;
Lot 5HM488, exp. 07/07; Lot 5HM503, exp. 07/07;
b) Lot 5HM500, exp. 07/07; Lot 5HM499, exp.
07/07
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Pharmaceutical Sourcing Group, Raritan, NJ
Manufacturer: Ortho Pharmaceutical,
Manati, PR.
REASON Microbial Contamination
VOLUME OF
PRODUCT IN COMMERCE 29,624 tubes
DISTRIBUTION Nationwide
PRODUCT Scalp Ointment with 1%
Hydrocortisone in the following sizes: 1 oz. plastic jar (item #FL7301), 16 oz.
plastic jar (item #FL7316) and 1 gallon plastic bottle (item #FL73128).
CODE
Lot # 07051149
RECALLING
FIRM/MANUFACTURER Coats Aloe International, Inc., Garland, TX
REASON
Misbranding: Labeling is not in
compliance with regulations.
VOLUME OF PRODUCT IN COMMERCE 116
units
DISTRIBUTION Nationwide
Bedford Labs Initiates Nationwide Recall of Injectable Methotrexate
Bedford Laboratories, a division of Ben Venue Laboratories, Inc., Bedford, Ohio, announced that it is voluntarily recalling one lot of Methotrexate for Injection (preservative free), USP 1 gram per vial (NDC 55390-143-01), Lot# 859142, exp 09/07. Bedford Laboratories was informed by the manufacturer of the Methotrexate USP active drug substance (“ADS”) that the ADS used to manufacture Lot # 859142, contained low levels of ethylene glycol. Human use of preservative free Methotrexate formulations for intrathecal administration containing ethylene glycol is not permissible. Consumers that have received this product and have questions should contact their physicians.
The prescription product was distributed throughout the United States in October and November 2005 to wholesalers and distributors, who further distribute the product to hospitals. Customers that have any vials of this one lot of Methotrexate for Injection have been instructed to discontinue distribution and use of this lot immediately and contact Bedford Laboratories Customer Service Department (1-800-562-4797) for a returned goods authorization. Consumers that have questions regarding this recall should also contact the Bedford Customer Service Department at 1-800-562-4797, between the hours of 8 a.m - 5 p.m (EST).
WEEK ENDING DECEMBER 17
PRODUCT Zoloft (Sertraline HCl)
60 mL, oral concentrate, 20mg/mL, Rx only, NDC 0049-4940-23, CODE Lot numbers 0105082, 0105083 and 0105084 NDC
0049-4940-23
RECALLING FIRM/MANUFACTURER U.S. Pharmaceuticals
Group, New York, NY
REASON Presence of particulate matter: there is a
potential that a small number of pouches containing the glass droppers used to
dispense the medication may contain small fragments of glass.
VOLUME OF
PRODUCT IN COMMERCE Lot 0105082 - 10,824 units; Lot 0105083 - 13,583
units; 0105084- 1,835 units
DISTRIBUTION Nationwide
PRODUCT GenTeal GelDrops
Lubricant Eye Drops, Sterile 15 mL and 25 mL vials, OTC, NDC 0078-0425-24 and
0078-0425-16.
CODE Lot 51139, exp. JUL 07; Lot
51283, exp. JUL 07
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Novartis Pharmaceuticals Corporation, East Hanover, NJ
Manufacturer:
Ciba Vision Sterile Pharmaceuticals, Mississauga, Ontario, Canada.
REASON
Lack of assurance of
sterility
VOLUME OF PRODUCT IN
COMMERCE 11832
DISTRIBUTION Nationwide
PRODUCT Equate brand Ibuprofen
Liquid Softgels, 200 mg, 180 Liquid Filled Capsules, Pain Reliever/Fever
Reducer, over-the-counter
CODE 4NB0562, 4PB0418,
4PB0618, 5CA0271, 5CA0390, 5BA0360, 5BA0631, 5CA0225, 5CA0227, 5CA0229, 5CA0230,
5CA0231, 5CA0232, 5CA0233, 5CB0273, 5CB0274, 5CB0275, 5DA0571, 5DA0951, 5DA0952,
5DA0954, 5DA0960, 5DB0251, 5DB0252, 4NB0563, 5AB0386, 5BB0786, 5CB0281, 5DB0537,
4NB0565, 5AB0083, 5BB0785, 5CB0830, 5DB0256, 4NB0558, 5BB0475, 5BB0787, 5CB0823,
5DB0255, 5EB0673, 4NB0564, 4PB0312, 4PB0624, 5AB0603, 5BB0784, 5EB0672, 4NB0539,
4NB0538, 4MB0711, 4MB0712, 4MB0713, 4NB0945, 4NB1049, 4PB0300, 5AB0602, 5BB0019,
5BB0470, 5CB0552, 5CB0827, 5BD0004, 5DB0538, 5EB0058, 5EB0258, 5EB0671, 5FB0097,
5FB0405, 5FB0949, 5GB0292, 4NB0943, 5AB0079, 5AB0217, 5AB0498, 5AB0586, 5BB0021,
5CB0283, 5CB0553, 5CB0825, 5DB0005, 5DB0259, 5EB0257, 5EB0370, 5EB0668, 5FB0095,
5FB0403, 5GB0109, 4NB0944, 5AB0080, 5AB0594, 5BB0020, 5CB0826, 5DB0006, 5DB0539,
5EB0291, 5EB0667, 5FB0202, 5FB0726, 5FB0948, 5GB0108, 4PB0309, 5EB0368, 5FB0204,
5GB0285, 4PB0313, 5EB0057, 4NB0567, 4PB0303, 5AB0356, 5DB0535, 5EB0051, 5EB0365,
5EB0663, 5FB0098, 4NB0561, 4PB0307, 5DB0254, 5DB0533, 5EB0053, 4NB0566, 4PB0305,
5EB0289, 4NB0340, 5AB0084, 4MB0660, 4MB0661, 4MB0662, 4MB0657, 4MB0658, 4MB0659,
4NB0261, 4NB0341, 4NB1045, 5AB0081, 5AB0599, 4NB0261, 4NB0262, 4NB0263, 4NB0264,
4PB0311, 5BB0476, 5BB0791, 5CB0282, 5EB0669, 4NB0338, 4PB0302, 5EB0366, 5FB0407,
4NB0559, 5EB0055, 5EB0675, 5GB0688, 4NB0560, 4NB0339, 5AB0355, 5CB0278, 5CB0829,
5EB0670, 4MB0669, 4MB0670, 4BP0621, 5BB0789, 5CB0824, 5EB0290, 4NB0164, 4PB0304,
4PB0619, 5BB0471, 5CB0280, 5DB0257, 5BD0536, 5EB0052, 5EB0367, 5FB0727, 4MB0663,
4MB0664, 4NB0555, 4PB0622, 5BB0473, 5BB0788, 5CB0822, 5DB0253, 5DB0534, 5EB0054,
5CB0754, 5DB0292, 5DB0590, 5EB0020, 5EB0498, 4NB0336, 4PB0301, 5AB0082, 5BB0472,
5BD0258, 5EB0666, 5FB0096, 5FB0725, 4MB0556, 4PB0310, 5AB0357, 5BB0474, 5GB0474,
5GB0284, 4NB0337, 5CB0279, 4NB0335, 4PB0623, 5FB0099, 5FB0728
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products Llc,
Carson, CA
Manufacturer: Banner
Pharmacaps Inc, High Point, NC.
REASON Subpotent; clumping and leaking
softgels
VOLUME OF PRODUCT IN COMMERCE 2,502,692
bottles
DISTRIBUTION Nationwide
PRODUCT Altace, Ramipril
Capsules, 2.5mg, unit dose pack (10s), Rx only, NDA 19-901, NDC 61570-111-56
CODE
Lot Number: 1068711
RECALLING
FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc,
Bristol, TN
Manufacturer: Aventis
Pharmaceuticals, Inc., Kansas City, MO.
REASON Expiry date not clearly printed.
VOLUME OF
PRODUCT IN COMMERCE 12,179 units
(cartons)
DISTRIBUTION Nationwide
PRODUCT Tylenol Arthritis
Extended Relief Caplets 100 count bottle, Acetaminophen 650 mg per caplet,
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC, INC,
Fort Washington, PA 19034, NDC 50580-112-10
CODE Lot number JHM048 exp 2/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer & Specialty
Pharmaceuticals, Division of McN, Fort Washington, PA, Manufacturer: McNeil Consumer and Specialty
Pharmaceuticals, Las Piedras, PR.
REASON Product intended for destruction due to bulk
containers being torn was possibly diverted to retail stores.
VOLUME OF
PRODUCT IN COMMERCE Unknown
DISTRIBUTION Unknown
WEEK ENDING DECEMBER 24
PRODUCT Children’s Motrin Grape
Suspension 4 oz. Ibuprofen 100 mg/5 ml suspension, Pain Reliever/Fever Reducer,
NDC # 50580-603-04
CODE Lot number JAM129 exp.
1/07
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty
Pharmaceuticals, Division of McN, Fort Washington, PA
REASON Product intended
for destruction due to microbial contamination was possibly diverted to retail
stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Children’s Motrin Berry
Suspension 4 oz. Ibuprofen 100 mg/5 ml, OTC Pain Reliever/Fever Reducer, NDC #
50580-601-04
CODE Lot number JFM179 exp
6/07
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty
Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Presence of foreign matter: Product intended for
destruction due to a lint free cloth found on an in-line screen was possibly
diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Infant Tylenol
Concentrated Drops Cherry Flavor 1 oz. Acetaminophen 80 mg/0.8 ml, OTC, NDC #
50580-186-30
CODE Lot number HLM187 exp
10/05
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty
Pharmaceuticals, Division of McNeil, Fort Washington, PA
REASON Presence of particulate matter: Product intended
for destruction due to the potential of metal shavings in the product was
possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Unknown
PRODUCT Methotrexate Active
Pharmaceutical Ingredient, Bulk Powder, 10kg, 10.5kg and 20kg drums, Rx only -
For manufacturing, processing, or repacking, NDC 12780-0491-0, CAS-59-05-2, CODE
Batch No. 1098057; 1097859; 1101822;
1098687
RECALLING FIRM/MANUFACTURER
Recalling Firm: SST
Corporation, Clifton, NJ
Manufacturer: Orion Corporation Fermion,
Espoo, Finland.
REASON Methotrexate API contaminated with Ethylene Glycol
during manufacture.
VOLUME OF PRODUCT IN COMMERCE 140.5
kg
DISTRIBUTION IL, OH, VA, and PR
PRODUCT Darvon Compound (propoxphene hydrochloride, aspirin and caffeine capsules), USP * 65 mg * NDC
66591-612-41 * 100 Pulvules * Rx only
CODE Lot
03246A, 03247A and 03248A, 04190A, 04210A, 05015A, 05029A, 05057A,
05057B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Xanodyne
Pharmaceuticals, Inc., Florence, KY
Manufacturer: Aaipharma, Wilmington, NC.
REASON
Dissolution Failure: aspirin and propoxyphene
hydrochloride (18 month stability)
VOLUME OF PRODUCT IN
COMMERCE 85,252 bottles/100 count
bottles
DISTRIBUTION Nationwide
WEEK ENDING DECEMBER 31
PRODUCT
a) Liqiang 1 Herbal
Supplement Capsules, (Codonopsis 67.5mg, Astragalus Root 67.5mg, Figwort
Root 67.5mg, Mai Dong 45.00mg, Sciomon’s Root 67.5mg, Anemarrena
37.35mg, Polygonatum 37.35mg and Tian Hua Fen 60.30mg)90 Caps x 450 mg bottles
b) Liqiang 4 Herbal Supplement Capsules,
(Codonopsis 67.5mg, Astragalus Root 67.5mg, Red Sage Root 13.5mg, Poria
Rubra 38.25mg, White Atractylodes 67.5mg, Rehmannia 67.5mg, Chinese Wolberry
Root Bark 90mg, and Wild Yam 38.25mg)90 Caps x 450 mg bottles
c) Liqiang 5 Capsules,
(Trichosanthes Root, Dried Rehmannia
Root, Figwort Root, and Chinese Magnoliavine), 90 Caps bottles
CODE All lots and codes
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Bugle International, Inc.,
Northridge, CA
Manufacturer: Henan Yilong Import & Export Co. Limited,
Zhengzhou, China.
REASON Unapproved New Drug found to contain undeclared
prescription drug Glyburide.
VOLUME OF PRODUCT IN
COMMERCE 128,000
DISTRIBUTION Nationwide and Canada
PRODUCT
a) Ultra-TechneKow
DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from
Fission Produced Molybdenum 99, Catalog number N8831L (1.0 curie),
b) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m
Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99, Catalog number N8841L (1.5 curies).
c)
Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum
99 prepared from Fission Produced Molybdenum 99, Catalog number N8851L ,
2L (2.0 curies),
d) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from Fission
Produced Molybdenum 99, Catalog number 8861L, 2L (2.5 curies).
e) Ultra-TechneKow
DTE, UTK-DTE, Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99,
Catalog number N8871L, 2L (3.0 curies).
f) Ultra-TechneKow DTE, UTK-DTE, Technetium
Tc 99m Generator, Parent Molybdenum
99 prepared from Fission Produced Molybdenum 99, Catalog number N8881L,
2L (3.5 curies),
g) Ultra-TechneKow DTE, UTK-DTE,
Technetium Tc 99m Generator, Parent Molybdenum 99 prepared from Fission
Produced Molybdenum 99, Catalog numbers N8891L, 2L and N8891T, 2T (5.0
curies).
h) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc
99m Generator, Parent Molybdenum 99 prepared from Fission Produced
Molybdenum 99, Catalog numbers N8901L, 2L, and N8901T, 2T, (6.0 curies).
i)
Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m
Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum
99, Catalog numbers N8911L, 2L, and N8911T, 2T, (7.5 curies).
j) Ultra-TechneKow
DTE, UTK-DTE, Technetium Tc 99m Generator,
Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99,
Catalog number N8921D, 2D (11.0 curie).
k) Ultra-TechneKow DTE, UTK-DTE, Technetium
Tc 99m Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum 99, Catalog number
N8931D, 2D (14.0 curie).
l) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m Generator, Parent Molybdenum 99
prepared from
Fission Produced Molybdenum 99, Catalog number N8941D, 2D (16.0 curie).
m) Ultra-TechneKow DTE, UTK-DTE, Technetium Tc 99m
Generator, Parent Molybdenum 99 prepared from Fission Produced Molybdenum
99, Catalog number N8951D, 2D (19.0 curie)
CODE
a) Lot 5176, Exp. 11/18/05; Lot 5178,
Exp.
11/21/05; Lot 5180, Exp. 11/25/05; Lot 5182, Exp. 11/28/05;
b) Lot 5176,
Exp. 11/18/05; Lot 5180, Exp. 11/25/05;
c) Lot 5176, Exp. 11/18/05; Lot
5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05;
Lot 5182, Exp. 11/28/05;
d) Lot 5176, Exp. 11/18/05; Lot 5178, Exp.
11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5182, Exp. 11/28/05;
e) Lot 5176, Exp. 11/18/05; Lot 5178,
Exp. 11/21/05;
Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5182, Exp.
11/28/05;
f) Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5179,
Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5182, Exp. 11/28/05;
g)
Lot 5176, Exp. 11/18/05; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5182,
Exp. 11/28/05;
h) Lot 5176, Exp.
11/18/05; Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05;
i) Lot 5176,
Exp. 11/18/05; Lot 5177, Exp. 11/20/2005; Lot 5178, Exp. 11/21/05; Lot
5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, 11/27/05; Lot
5182, Exp. 11/28/05;
j) Lot 5176, Exp. 11/18/05; Lot 5177, Exp.
11/20/2005; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, 11/27/05;
Lot 5182, Exp. 11/28/05;
k) Lot
5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/2005; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180,
Exp. 11/25/05; Lot 5181, 11/27/05; Lot 5182, Exp. 11/28/05;
l) Lot 5176, Exp. 11/18/05; Lot 5177,
Exp.
11/20/2005; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180, Exp. 11/25/05; Lot 5181, 11/27/05;
Lot 5182, Exp. 11/28/05;
m) Lot
5176, Exp. 11/18/05; Lot 5177, Exp. 11/20/2005; Lot 5178, Exp. 11/21/05; Lot 5179, Exp. 11/23/05; Lot 5180,
Exp. 11/25/05; Lot 5181, 11/27/05; Lot 5182, Exp. 11/28/05.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt, Inc., St. Louis,
MO
Manufacturer: Mallinckrodt Inc., Maryland Heights, MO.
REASON
Lack of assurance of sterility: Positive
unit found in a media fill run.
VOLUME OF PRODUCT IN COMMERCE 1,646
generators
DISTRIBUTION Nationwide and Internationally
PRODUCT Dollar General Delight brand Dishwashing Liquid Antibacterial Hand Soap, Orange Blossom, 50 fl. oz.
CODE
Lots 10105T, 10115T and
10125T
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Korex,
Wixom, MI,
Manufacturer: Korex Don Valley ULC, Toronto, Canada.
REASON
Microbial contamination:
Contaminated with the bacteria Pseudomonas aeruginosa.
VOLUME OF PRODUCT
IN COMMERCE 18,978 bottles
DISTRIBUTION Nationwide
PRODUCT Prednisolone Oral
Solution, USP 15 mg/5mL (formerly Prednisolone Syrup, USP 15 mg/5 mL); packaged
in 8 fl. oz. and 16 fl. oz. PET bottles; an Rx oral glucocorticoid, product
8137; NDC 60431-137-08 (8 oz) and 60432-137-16 (16 oz)
CODE
8 oz: lot numbers 26503A and 27163A;
16 oz: lot
numbers 26504A, 26505A and 26625A
RECALLING
FIRM/MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, IL
REASON
Degradant/Impurity level exceeded specification
requirements of not more than 0.50%.
VOLUME OF PRODUCT IN
COMMERCE 8,617 -- 8 oz and 529 -- 16 oz
bottles
DISTRIBUTION Nationwide and PR
PRODUCT Children’s Tylenol Cold
Plus Cough Chewable Tablets. Each tablet contains acetaminophen 80 mg,
chlorpheniramine maleate 0.5 mg, dextromethorphan HBr 2.5 mg, pseudoephedrine
HCI 7.5 mg, CODE Lot number HPM086 exp
11/05
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty
Pharmaceuticals, Division of McN, Fort Washington, PA
REASON
Superpotent:
Product intended for destruction due to out of specification result for
pseudoephedrine HCI assay was possibly diverted to retail stores.
VOLUME
OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide
PRODUCT Deluxe Dish Detergent
Antibacterial Hand Soap, 50 oz.
CODE Lot numbers:
(Manufacturing Dates): Tues-Oct. 11, 2005: 284525AA3, 284525AA4, 284525AA5,
284525AA6; Wed. Oct. 12, 2005: 285525AA1, 285525AA3, 28525AA4; Fri. Feb. 25,
2005: 056530AA1, 056530AA2, 056530AA3, 056530AA4, 056530AA5; Mon. Feb. 26, 2005:
059530AA1, 059530AA2, 059530AA3, 059530AA4, 059530AA5, 059530AA6: Tues. Feb. 27,
2005: 060530AA1, 060530AA2, 060530AA3, 060530AA4, 060530AA6, 060530AA8,
060530AA9 and Wed. Feb. 28, 2005: 061530AA8, 061530AA9
RECALLING
FIRM/MANUFACTURER Showline, Raleigh, NC
REASON Misbranded: Lack of
active ingredient, Triclosan
VOLUME OF PRODUCT IN COMMERCE 13,068
cases
DISTRIBUTION Nationwide
PRODUCT Extra Strength Tylenol
Caplets 2 count pouches. Acetaminophen 500 mg per caplet. The product is sold in
cartons containing 50 pouches, OTC
CODE Lot
number JSM091 exp 9/08
RECALLING FIRM/MANUFACTURER McNeil Consumer
& Specialty Pharmaceuticals, Division of McN, Fort Washington, PA
REASON
Product intended for destruction due to out of
specification result because 3 caplets were released into packaging instead of 2
caplets which was possibly diverted to retail stores.
VOLUME OF PRODUCT IN
COMMERCE Unknown
DISTRIBUTION Nationwide