JULY 2007
WEEK ENDING JULY 7
PRODUCT Listerine
Agent Cool Blue Plaque-Detecting Rinse, Glacier Mint Flavor, 250 mL and 500 mL
bottles,
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil
PPC, Inc., Morris Plains, NJ
Manufacturer: McNeil PPC, Inc., Lititz, PA.
REASON
Firm’s testing confirmed
microbial contamination in some bottles, including gram negative
organisms.
VOLUME OF PRODUCT IN COMMERCE 9,500,000
bottles
DISTRIBUTION Nationwide including PR
PRODUCT Listerine
Agent Cool Blue Plaque-Detecting Rinse, Bubble Blast Flavor, 250 mL and 500 mL
bottles,
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil
PPC, Inc., Morris Plains, NJ,
Manufacturer: McNeil PPC, Inc., Lititz, PA.
REASON
Product may be contaminated
with gram negative microorganisms.
VOLUME OF PRODUCT IN
COMMERCE 9,500,000
bottles
DISTRIBUTION Nationwide including
PR
PRODUCT
a)
Colgate Toothpaste, Sodium Monoflorophosphate 0.76% 5 oz (100ml) tube, Regular,
b) Colgate Toothpaste,
Sodium Monoflorophosphate 1.1%, 5 oz (100ml) tube,
Herbal, Colgate Herbal,
c) Colgate Toothpaste, 0.76%
Sodium, Monoflorophosphate 0.10% sodium
fluoride, 5 oz
(100ml) tube Colgate Gel,
d) Colgate
Toothpaste, Sodium Monoflorophosphate 0.76% 5 oz (100ml) tube, Triple with Germ Defense,
CODE
a) Regular 3400 2008 UPC 6 001067
066613;
b) Herbal: MNF 04 2005 OB EXP 04 2008 UPC 6 001067 021452;
c) Gel:
50712A10 UPC 6 001067 066293;
d) All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: MS USA Trading, Inc., North
Bergen, NJ
Manufacturer: Colgate Palmolive (PTY) LTD, Boskburg, South
Africa. REASON Toothpaste may contain Diethylene
Glycol
VOLUME OF PRODUCT IN COMMERCE 122 cases (144 tubes
per case)
DISTRIBUTION MD, NJ, NY and PA
WEEK ENDING JULY 14
PRODUCT V.MAX
Herbal Stamina Enhancer for Men Dietary Supplement, Cordyceps Militaries, L-Arginine, Psylium Husk Powder, Licorice Root, Astragalus
Membranaceus, Steamed
Panax Ginseng, Zinc Oxide, 0.5g, 15 Capsules cartons,
CODE
VM0501
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Barodon S.F., Inc., Los
Angeles, CA,
Manufacturer: MegaCare Inc., Las Vegas, NV,
REASON
Unapproved New Drug - product
has been found to contain Aminotadalafil an analogue of tadalafil, a drug used
to treat erectile dysfunction.
VOLUME OF PRODUCT IN
COMMERCE 200,000
capsules
DISTRIBUTION Nationwide, South Korea and
Japan
PRODUCT Crescent
brand toothpaste & Crescent toothpaste with toothbrush, Net Wt 181g, labeled
ingredients include Sodium Monofluorophosphate O.7% and Sorbitol, MADE IN CHINA,
CODE
All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: H & Y Trading Co., Capitol
Heights, MD,
Manufacturer: Shandong
Chiping Foreign Trade Prod, Taiyun, China.
REASON Toothpaste from China may contain the poisonous
chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE 300 tubes
DISTRIBUTION MD and
D.C.
PRODUCT
a)
Dr.cool Toothpaste Coolmint , Net Wt 120g, labeled ingredients include Sodium Monoflurophosphate 0.5% and
Diglycol. Product of China,
b) Coolmint Toothpaste and Superdent Coolmint Toothpaste with
toothbrush, Net Wt 120g, labeled ingredients include Sodium
Monoflurophosphate 0.5% and Diglycol. Product of China,
c) Everfresh Assortment Toothpaste and Everfresh 1 + 1 Assortment
Toothpaste with toothbrush, 25ml, labeled as 'Cavity Fighter',
CODE
a) Bar Code: 6926597170008;
b) Bar
Code: 6926597170015;
c) Bar Code: 6926597089539
RECALLING
FIRM/MANUFACTURER
Recalling Firm: MainStar America, LLC,
Miami, FL,
Manufacturer: Goldcredit
International Enterprises, Wuxi, Jiangsu, China. REASON Toothpaste from China that
contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF
PRODUCT IN COMMERCE 4,966
units
DISTRIBUTION FL, PR, and Guatemala
PRODUCT EDTA,
Disodium Salt Dihydrate, USP (Ethylenediamine Tetraacetic Acid, Disodium Salt
Dihydrate), bulk drug for laboratory and commercial manufacturing use packaged
in 500 g plastic bottles and 12 Kg plastic pails, catalogue numbers S312 and
S316, CAS 6381-92-6, Product of India,
CODE Lots: 066078 and
065543
RECALLING FIRM/MANUFACTURER
Recalling Firm: Thermo
Fisher Scientific Co., LLC, Fair Lawn, NJ,
Manufacturer: Indian
Chem-Port, Makarpura Baroda, India.
REASON Product exceeds USP
specification for nitrilotriacetic acid impurity.
VOLUME OF PRODUCT
IN COMMERCE 72.5 Kg
DISTRIBUTION Nationwide
and Canada
WEEK ENDING JULY 21
PRODUCT SaniClenz
Antimicrobial Cleanser (chlorhexidine gluconate) contains 2% w/w Chlorhexidine
gluconate with 2% isopropyl alcohol in a nonalkaline base. Enriched with Aloe
Vera and Vitamin E. For External use only, 18 fl. oz or 1 gallon Crosstex
International NDC058575-320 Reorder Ref # JSCP,
CODE Lot numbers 2320, 2336, 2400, 2461 and
2483
RECALLING FIRM/MANUFACTURER Inopak, Ltd., Ringwood,
NJ, REASON Product was mislabeled as “SaniTyze”
rather than “SaniClenz” and also possible bacterial
contamination.
VOLUME OF PRODUCT IN COMMERCE 1152 units
of 1 gallon and 4224 units of 18
oz
DISTRIBUTION NY
PRODUCT Alupent®
Inhalation Aerosol, (metaproterenol sulfate, USP) Inhalation Aerosol with
mouthpiece, Net Contents 14g (10 ml), Metered Dose Inhaler, 200 metered doses,
CODE
Lot Numbers: 050912W, expiration
date Dec 07 and lot # 060359W, expiration date Jun 08.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Corp.,
Columbus, OH,
Manufacturer: 3M Company,
Northridge, CA.
REASON Product failed particle size distribution
analysis during stability.
VOLUME OF PRODUCT IN
COMMERCE 137,491
canisters
DISTRIBUTION Nationwide
PRODUCT
Fluoride
Toothpaste, Sodium Monofluorophosphate, made in China; sold under the following
labels:
a) EverFRESH Fluoride Toothpaste, Exclusive; 1 tube per box, 144
boxes per case; in 1.5 oz tubes, item TP00015, UPC
766851000155 and 2.75 oz tubes, item TP00275, UPC 766851002753;
b) McKesson
Medi-Pak EverFRESH Fluoride Toothpaste, Mint Flavor, in 0.6 oz tubes, reorder 16-TP6, UPC (01)10612479150642, 144 tubes per
case, 5 cases per master carton; 1.5 oz tubes reorder
16-TP15, UPC (01)20612479128914, 1 tube per box, 144 boxes per case; 2.75 oz tubes reorder 16-TP275, UPC (01)20612479128921, 1
tube per box, 144 boxes per case,
CODE All lots within 3 year
expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Cypress Medical Products, Ltd., McHenry, IL,
Manufacturer: Suzhou Qingxin Daily Chemical Co, Ltd,
Suzhou,
China. REASON The
toothpaste, manufactured in China, may contain a poisonous chemical, diethylene
glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE 36,190
cases
DISTRIBUTION Nationwide
PRODUCT Pulmicort
Respules (budesonide inhalation suspension) 0.5mg/2mL, RX, Product from Sweden
NDC 0186-1989-04
CODE
Lot Number:
NB0022 Exp Date FEB 2009 Expanded Recall: Lot Exp. Date NA0052 Jan 2009 NA0083
Jan 2009 NA0088 Jan 2009 NA0090 Jan 2009 NA0091 Jan 2009 NA0092 Jan 2009 NA0128
Jan 2009 NA0129 Jan 2009 NA0130 Jan 2009 NA0132 Feb 2009 NA0133 Jan 2009 NA0134
Jan 2009 NA0135 Jan 2009 NA0136 Feb 2009 NB0009 Feb 2009 NB0010 Feb 2009 NB0012
Feb 2009 NB0022* Feb 2009 NB0044 Feb 2009 NB0046 Feb 2009 NB0047 Feb 2009 NB0050
Feb 2009 NB0051 Feb 2009 NB0053 Feb 2009 NB0087 Feb 2009 NB0088 Feb 2009 NB0089
Feb 2009 NB0090 Feb 2009 NB0091 Feb 2009 NB0092 Feb 2009 NB0093 Feb 2009 NB0094
Feb 2009 NB0095 Feb 2009 NB0096 Feb 2009 NB0097 Feb 2009 NB0098 Feb 2009 NB0099
Feb 2009 NB0100 Feb 2009 NB0163 Mar 2009 NB0164 Mar 2009 NB0166 Mar 2009 NC0035
Mar 2009 NC0048 Mar 2009 NC0050 Mar 2009 NC0055 Mar 2009 NC0056 Mar 2009 NC0057
Mar 2009 NC0058 Mar 2009 NC0060 Mar 2009 NC0061 Mar 2009 NC0085 Mar 2009 NC0088
Mar 2009 NC0089 Mar 2009 NF0052 Apr 2009 NF0065 Apr 2009 NF0071 Apr 2009
*Product recalled June 12,2007
RECALLING
FIRM/MANUFACTURER AstraZeneca LP, Westborough, MA,
REASON
Contamination; product has off odor/off
taste due to ethyl acetate used in the production of the foil.
VOLUME
OF PRODUCT IN COMMERCE 896,000
units
DISTRIBUTION Nationwide
PRODUCT Dantrolene
Sodium Capsules, 25 mg, 100 capsule bottle, Rx only, NDC 52152-219-02,
CODE
Lots: 60243A1, exp. 3/08; 60244A1, exp.
3/08; 60245A1, exp. 3/08
RECALLING
FIRM/MANUFACTURER Actavis Totowa LLC, Little Falls, NJ
REASON
Product failed dissolution specification
at 12 months.
VOLUME OF PRODUCT IN COMMERCE 14,349/100
capsule
bottles
DISTRIBUTION Nationwide
PRODUCT Lithium
Carbonate Extended-Release Tablets, USP, 450 mg, 30-tablet bottle, Rx only, NDC
0143-1277-30,
CODE Lot: 62395A, exp.
3/08
RECALLING FIRM/MANUFACTURER West-Ward Pharmaceutical
Corp, Eatontown, NJ,
REASON Tablets packaged in 30 count bottles did not
meet the 3-hour dissolution specifications at the 12 month stability
station.
VOLUME OF PRODUCT IN COMMERCE 72/30 tablet
bottles
DISTRIBUTION VT, ND and PR
WEEK ENDING JULY 28
PRODUCT AZMACORT
(triamcinolone acetonide) Inhalation Aerosol - One 20g Inhaler - 240 Metered
Actuations - Rx only,
CODE Lot #
BAA211 Expiration date: 08/08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott
Park, IL
Manufacturer: INyX USA, Ltd., Manati, PR.
REASON Presence of foreign substance.
VOLUME
OF PRODUCT IN COMMERCE 2,184
packages
DISTRIBUTION NV, NY and
TN
PRODUCT Advil®
Tablets (Ibuprofen), 200 mg, UPC 3-0573-0154-17-8,
CODE
B83369 Exp 08/08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Wyeth Consumer Healthcare,
Madison, NJ
Manufacturer:
Wyeth Pharmaceuticals Company, Guayama, PR.
REASON
Incorrect Expiration Date; product
incorrectly labeled as "80/08" rather than correctly as
"08/08".
VOLUME OF PRODUCT IN COMMERCE 360 cases. 2 count
foil pouches/3000 pouches/case
DISTRIBUTION CA