NOVEMBER 2007
WEEK ENDING NOVEMBER 3
PRODUCT Metaboslim
All Natural Fat Eater Apple Cider Vinegar Dietary Supplement, 60-capsule
bottles, UPC 92483 00102, Confidence USA,
CODE Lot 3001006, exp.
102009
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Confidence Inc., Port Washington, NY
Manufacturer: Island Vitamins Inc.
Farmingdale, NY.
REASON Product was found to contain undeclared
sibutramine, an active pharmaceutical ingredient used for weight loss in
treatment of obesity.
VOLUME OF PRODUCT IN COMMERCE 4,180
bottles
DISTRIBUTION Canada
PRODUCT BETCO WINNING HANDS ULTRA MILD ANTIBACTERIAL SKIN CLEANSER, Triclosan 0.30%,
NET CONTENTS 30.4 fl. oz. (900 mL) bag in box, 37.2 fl. oz. (1100 mL) bag in
box, 67.7 fl. oz. (2000 mL) bag in box, 1 Gallon (3.78L) bottles, CODE
1 Gallon Bottle (4-1 Gallon Containers
per case) Lots 1088639, 1089891, 1087387 --- 900 mL BAG IN BOX (12-900 mL per
case) Lot 1088201 --- 1100 mL BAG IN BOX (10-1100 mL per case) Lot 1088201 ---
2000 mL BAG IN BOX (4 - 2000 ml per case) Lot 1090335
RECALLING
FIRM/MANUFACTURER Betco Corp., Ltd, Toledo, OH
REASON
Microbial contamination of Non Sterile
Product; the product is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
1,212
gallons
DISTRIBUTION Nationwide
PRODUCT
a) Dentakleen Cavity Fighting Fluoride Toothpaste, Great Regular Flavor, 6.4
oz tubes with free toothbrush, labeled ingredients
include Sodium Monofluorophosphate 0.7%. Made in China,
b) Dentakleen Fluoride Toothpaste, Fresh Mint Flavor,
6.4 oz tubes with free toothbrush, labeled ingredients
include Sodium Monofluorophosphate 0.7%. Made in China,
c) Dentakleen Fluoride Toothpaste, Cool Winterfresh
Taste, 6.4 oz tubes with free toothbrush, labeled
ingredients include Sodium Monofluorophosphate 0.7%. Made in China,
d) Denta-Kleen Junior
Fluoride Toothpaste, Blueberry Flavor, 50 g tubes with bonus toothbrush, labeled ingredients include
Monofluorophosphate 500 ppm. Made in China,
e) Denta-Kleen Junior Fluoride Toothpaste, Strawberry
Flavor, 50 g tubes with bonus toothbrush, labeled
ingredients include Monofluorophosphate 500 ppm. Made in
China,
CODE
All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: One Two
For You, Inc., Toa Baja, PR
Manufacturer:
Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland).
REASON
Toothpaste from
China containing the poisonous chemical diethylene glycol
(DEG).
VOLUME OF PRODUCT IN COMMERCE 18,720
units
DISTRIBUTION PR
PRODUCT Fougera CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP 1%/0.05%
(base), a) NET WT 15 grams (NDC 0168-0258-15) and b) NET WT 45 grams (NDC
0168-0258-46), Rx only,
CODE
a)
Lot T957 (exp. 11/07);
b) Lots T608 (exp. 9/07), T609 (exp. 9/07), T755
(exp. 11/07), T793 (exp. 11/07), U131 (exp. 12/07), U132 (exp. 12/07), U268
(exp. 1/08), U269 (exp. 1/08), U638 (exp. 2/08), U639 (exp. 2/08), U961(exp.
2/08), U962(exp. 4/08), U963 (exp. 4/08), W098 (exp. 7/08), W099 (exp.
7/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Altana,
Inc., Melville, NY
Manufacturer: Altana,
Inc., Hicksville, NY.
REASON Out-of-specification result for
homogeneity (low) at 21-month test station (controlled room temperature). Result
of 88.6% vs. specification of 90.0% -110.0% of the mean for
homogeneity.
VOLUME OF PRODUCT IN COMMERCE 772,814
units
DISTRIBUTION Nationwide, PR, Guam, and
Guyana
PRODUCT Pancrecarb MS-4
(pancrelipase) Delayed-Release Capsules, professional
sample, 20-capsule bottle, Rx only, NDC 59767-002-03,
CODE
Lot: 7C04A, exp.
04/09
RECALLING FIRM/MANUFACTURER Digestive Care, Inc.,
Bethlehem, PA
REASON Inner foil seal does not adhere to the
bottles.
VOLUME OF PRODUCT IN COMMERCE 1,134
bottles
DISTRIBUTION Nationwide
PRODUCT Ibuprofen Tablets, 200 mg tablets, 2 tablets per pack, OTC,
CODE Lot: HA09707, exp.
12/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Generic
Pharmacetical Services, Inc., Hauppauge, NY,
Manufacturer:
Interpharm, Inc.,
Hauppauge, NY.
REASON The bulk lot had failed USP limit for
4-IBA impurity during stability testing.
VOLUME OF PRODUCT IN
COMMERCE 1,412,376 pouches (2 tablets per
pouch)
DISTRIBUTION WA and
CA
PRODUCT
a) Ibuprofen Tablets USP, 200 mg, white or brown color, packaged in bulk cartons for further processing only and in bottles of 250 tablets, 500 tablets, and 1000 tablets. Bulk product manufactured for:
1) Leiner Health Products, LLC (HA05107);
2) Generic Pharmaceutical Services, (HA09707); 3) Kirk Pharmaceuticals, (HA09907). Product in bottles distributed under following labels:
1) Rugby Laboratories, 2)
InterPharm,
b) Ibuprofen Tablets USP, 400 mg, packaged in bulk carton for
further processing only,
c)
Ibuprofen Tablets USP, 600 mg, packaged in bulk carton for further processing
only,
d) Ibuprofen Tablets USP,
800 mg, packaged in bulk carton for further processing only,
e) Ibuprofen Tablets USP, 200 mg,
brown color caplet, packaged in bulk carton for
further processing only,
CODE
a) Bulk
lots: HA05107, exp. 12/08; HA09707, exp. 12/09; HA09907, exp.
12/09; and packaged lot HA09807, exp. 12/09;
b) Bulk
lot HA02607, exp. 06/09;
c) Bulk lot HA07607, exp. 06/09;
d) Bulk lots:
HA06907, exp. 06/09 and HA15507, exp. 06/09;
e) Bulk lot HA18107, exp.
12/08
RECALLING FIRM/MANUFACTURER Interpharm, Inc.,
Hauppauge, NY
REASON Product
cannot meet impurity specification throughout shelf life.
VOLUME OF
PRODUCT IN COMMERCE
200mg: 4,648 bottles & 11,471,661 tablets;
400mg: 1,456,558 tablets; 600mg: 964,062 tablets; 800mg: 2,908,240 tablets;
200mg brown caplets: 2,858,582
DISTRIBUTION NY, PA, IL,
MI, OH, GA, FL, TX, CA, KY
Recall of 'True Man Sexual Energy,' 'Energy Max' Dietary Supplements
Recall of True
Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's
Formula Capsules, illegal drug products that contain potentially harmful,
undeclared ingredients. The products, often advertised as ``all natural''
alternatives to approved erectile dysfunction drugs, could interact with
medications and cause dangerously low blood pressure. They contain substances
that have similar structures to active ingredients in approved prescription
drugs.
The products are often advertised in newspapers, retail stores, and on the
Internet.
As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.
The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Customers who have either product in their possession should stop using it immediately and contact their health care provider if they have experienced any problems that may be related to taking this product.
WEEK ENDING NOVEMBER 10
PRODUCT Methylprednisolone
Acetate Injectable Suspension, USP 80 mg/ml. The product is shipped as 25 single
unit vials or 40 twenty-five unit vials,
CODE Lot number: 07J704 exp 1/31/2009 and Lot
number: 07K702 exp 1/31/2009
RECALLING
FIRM/MANUFACTURER
Recalling Firm: TEVA Pharmaceuticals USA, Inc.,
Sellersville, PA,
Manufacturer: Teva
Parenteral Medicines Inc., Irvine, CA,.
REASON Lack of assurance of
sterility.
VOLUME OF PRODUCT IN COMMERCE 80,254
vials
DISTRIBUTION Nationwide
PRODUCT
a) Top Care brand Tussin DM, cough suppressant expectorant for children and
adults, alcohol free, active ingredients (in each 5 mL
teaspoonful): Dextromethorphan HBr 10 mg and Guaifenesin
100 mg, 8 fl. oz.. bottles, NDC 36800-359-34, OTC,
b) Good Neighbor Pharmacy brand Tussin DM, cough suppressant
expectorant for children and adults, alcohol and sugar
free, active ingredients (in each 5 mL teaspoonful):
Dextromethorphan HBr 10 mg and Guaifenesin 100 mg, 4 fl. oz.. bottles, NDC 24385-578-26, OTC,
CODE
a) Lot 7HK0118, exp. 06/09;
b) Lot
7HK0044, exp. 06/09
RECALLING FIRM/MANUFACTURER L. Perrigo, Co.,
Allegan, MI,
REASON Some dosing cups
packaged with product lack the ½ teaspoon mark for dosing children 2 to 6 years
of age which could result in administration of twice the recommended dose of
dextromethorphan.
VOLUME OF PRODUCT IN COMMERCE 23,664
bottles (total number of bottles distributed for Recall #
D-029-032-2008)
DISTRIBUTION IL, MI, and
PA
PRODUCT Sunburst CHOLESTRIX Red Rice Yeast Extract, Standardized to contain 1.35%
Lovastatin, A Dietary Supplement, 90 Vegetable Capsules, Product #489 90. UPC 6
40313 48901 9,
CODE
Lot 5142 (exp.
8/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Sunburst Biorganics Inc., Baldwin, NY,
Manufacturer: Bactolac Pharmaceutical, Inc., Hauppauge, NY.
REASON
Unapproved new drug
marketed without an approved NDA/ANDA containing Lovastatin, the active
pharmaceutical ingredient in Mevacor.
VOLUME OF PRODUCT IN
COMMERCE 488 bottles (90 capsules per
bottle)
DISTRIBUTION Nationwide
PRODUCT Nutropin AQ Injection
(somatropin (rDNA origin), 10 mg in per vial, 2 mL
vials, Rx only,
CODE Lot number
N58562, expiration date 10/31/08, and lot number N63479, expiration date
03/31/2009
RECALLING FIRM/MANUFACTURER Genentech, Inc.,
South San Francisco, CA
REASON Mislabeled. Secondary carton may lack
labeling of expiration date and lot number.
VOLUME OF PRODUCT IN
COMMERCE 8,709
vials
DISTRIBUTION Nationwide
PRODUCT
a) Major brand Children's Mucus Relief Expectorant/Guaifenesin liquid, grape
flavor, active ingredient (in each 5 mL tsp): Guaifenesin
100 mg, 4 fl. oz.. bottles, NDC 0904-5814-20, OTC,
b) Children's Expectorant/Cough Suppressant liquid, cherry
flavor, alcohol free, active ingredients (in each 5 mL
tsp): Dextromethorphan HBr 5 mg and Guaifenesin 100 mg, 4
fl. oz . bottles. Packaged under the following brand names: 1) Major brand
Children's Mucus Relief Cough, distributed by Major
Pharmaceuticals, Livonia, MI (NDC 0904- 5815-20); 2)
Walgreens brand Children's Cough, (NDC 0363-0419-26); 3) Rite Aid
brand Children's Mucus Relief Cough,
CODE
a) Lot 7HK0065, exp. 06/09;
b) Lots
7HK0062, exp. 06/09 and 7HK0063, exp. 03/09
RECALLING
FIRM/MANUFACTURER L. Perrigo, Co., Allegan, MI,
REASON
Some dosing cups packaged with product
lack the ½ teaspoon mark for dosing children 2 to 6 years of
age.
VOLUME OF PRODUCT IN COMMERCE 23,664 bottles
DISTRIBUTION IL, MI, and
PA
PRODUCT Respi-Tann, Carbetapentane Citrate 20mg and Pseudoephedrine HCl 30mg Tannate
Suspension per each 5mL, 16 fl oz, Rx only,
CODE Lot number on shipping carton: EPS006,
exp 06/09; Lot number on unit bottle: EPS0D6
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ani Pharmaceuticals, Woodlawn, MD,
Manufacturer:
ANIP Acquisition Company,
Gulfport, MS.
REASON Lot number on unit bottle is
incorrect.
VOLUME OF PRODUCT IN COMMERCE 1,632
units
DISTRIBUTION TN
PRODUCT Otozone Otic Drops
(Chloroxylenol 1mg/ Hydrocortisone 10mg/Pramoxine HCI
10mg); Rx only,
CODE Lot #
60411
RECALLING FIRM/MANUFACTURER Elge, Inc., Rosenberg,
TX,
REASON Stability data does not support
expiration date. Product failed Prammoxine during stability.
VOLUME
OF PRODUCT IN COMMERCE 4,890
units
DISTRIBUTION TN
PRODUCT
a) Gabapentin Tablets, 600 mg, 100 & 500 tablet bottles, Rx only,
NDC 63304-592-01 and 63304-592-05,
b) Gabapentin Tablets, 800 mg, 100 & 500 tablet bottles, Rx
only, NDC 63304-593-01 and 63304-593-05,
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc.,
Princeton, NJ
Manufacturer: Ranbaxy
Laboratories, Limited, Simour District, India. REASON Product may exceed impurity specification
for Related Substances during shelf life.
VOLUME OF PRODUCT IN
COMMERCE 73,286,200
tablets
DISTRIBUTION Nationwide and PR
WEEK ENDING NOVEMBER 17
PRODUCT IPN
Therapy, Intraperitoneal Nutrition Solution in dialysate bags, 1 to 3 liter
volumes,
CODE Prescriptions filled on
or before 9/21/07.
RECALLING FIRM/MANUFACTURER Pentec
Health Inc, Boothwyn, PA,
REASON Increased incidence of fungal
peritonitis..
VOLUME OF PRODUCT IN COMMERCE 27,000
bags
DISTRIBUTION Nationwide
PRODUCT Cortisone Anti-Itch Cream (1.0% Hydrocortisone), Net Wt 1/2 oz tubes,
Also labeled as; Dr. Sheffield's Hydrocortisone Anti-Itch Maximum
Strength, Net Wt 1/2 oz tubes, IvySoothe, Net Wt. 1 oz., LandeRx Hydrocortisone,
Net Wt. 0.5 oz.,
CODE Lot Numbers:
005E1207 (Sheffield) 006E1207 (Sheffield) 01 1 E l 207 (Sheffield) 01 2E1207
(Sheffield) 079E02108 (Standard Homeopathic) 080E02/08 (Standard Homeopathic)
125E04108 (Lander) 128E04108 (Lander) 179E0508 (Sheffield) 180E0508
(Sheffield)
RECALLING FIRM/MANUFACTURER Sheffield
Laboratories, Division of Faria Limited LLC, New London, CT
REASON
Subpotent
VOLUME OF PRODUCT IN
COMMERCE 293,322
tubes
DISTRIBUTION Nationwide
PRODUCT Cefprozil for Oral Suspension
USP, 250 mg/5 mL, Rx only, in 50 mL bottles
(when mixed), 144 bottles/cases; NDC 0093-1076-76,
CODE
Lot number: 70532, exp
9/30/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm:
TEVA Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: TEVA Pharmaceutical USA, Inc., Fairfield, NJ.
REASON
Subpotent. 9 month
stability.
VOLUME OF PRODUCT IN COMMERCE 19,980
bottles
DISTRIBUTION Nationwide
WEEK ENDING NOVEMBER 24
Bodee LLC, Inc. Issues Recall of All Encore Tabs, a Product Marketed as a Dietary Supplement
Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, is recalling all the company's supplement product sold under the name Encore Tabs.
Bodee LLC is conducting this recall after samples found the product contains potentially harmful, undeclared ingredients.
Encore Tabs is sold in health food stores, via the internet and by mail order nationwide and in Canada. The Encore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
The company advises that any unused portion be returned to Bodee LLC for a full purchase price refund by calling (800) 935-0296 for instructions on the return and refund process.
PRODUCT Ampicillin for Injection, USP, ampicillin sodium equivalent to 250 mg ampicillin RX only; a lyophilized powder for injection antibiotic in a single dose vial, 10 vials per shelf carton; Made in Italy; product number 308710, NDC 63323-387-10,
CODE
Lot numbers:
7B04AJ, exp. 01/31/2010; 7D06AJ, exp. 03/31/2020; 7F07AJ, exp. 04/30/2010;
7G11AJ, exp. 05/31/2010. The recall was expanded on 11/8/07 to include lot
7A03AJ, Exp 12/31/2009
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abraxis Pharmaceutical Products,
Rosemont, IL,
Manufacturer: IBI -
Istituto Biochimico Italiano S.p.A, Aprilia, Italy. REASON Mislabeled; incorrect dilution
instructions printed on outer carton.
VOLUME OF PRODUCT IN
COMMERCE 200,700
vials
DISTRIBUTION Nationwide and
PR
PRODUCT
Potassium Citrate Extended Release Tablets USP, 10 mEq (1080 mg per tablet),
100-tablet bottles, Rx Only, NDC 64980-138-01, CODE Lot: CPF698, exp.
06/08
RECALLING FIRM/MANUFACTURER Corepharma LLC,
Middlesex, NJ
REASON Product may exceed impurity
specification for oxalic acid.
VOLUME OF PRODUCT IN
COMMERCE 3,503-100 tablet
bottles
DISTRIBUTION NJ
PRODUCT
Aspirin, enteric coated, 81 mg., OTC, packaged under the following brand
names: TOP CARE, 120 tablets, NDC 36800-535-76; Equate, 120 tablets, NDC
49035-535-76; American Fare, 365 tablets, NDC 49738-535-88; GoodSense, 120
tablets, NDC 0113-0535-76; Western Family, 120 tablets; Safeway, 120 tablets,
NDC 21130-535-76; Meijer, 120 tablets, NDC 41250-535-76; Sunmark, 120 tablets,
NDC 49348-756-53; H-E-B, 120 tablets, NDC 37808-535-76; Good Neighbor Pharmacy,
120 tablets, NDC 24385-535-76, and CARxEONE, 120 tablets,
CODE
Lots: 5GE0118, 5HE0086 and 5HE0589; Exp.
03/2008
RECALLING FIRM/MANUFACTURER L. Perrigo, Co., Allegan, MI,
REASON
Failed dissolution during 24 month
stability testing.
VOLUME OF PRODUCT IN COMMERCE 85,596
tablets
DISTRIBUTION Nationwide
PRODUCT Wyeth***ADD-Vantage
Vial NDC0206-8852-16***2.25gram Zosyn***Piperacillin and Tazobactam***for
injection***For IV Use***10x2.25 gram***,
CODE Lot # C00438 Exp. Date: April
2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth
Ayerst Laboratories, Philadelphia, PA,
Manufacturer: Wyeth Piperacillin Division of Wyeth Holdings Corp. Carolina,
PR.
REASON There is a
lack of assurance that the lots is within acceptable quality limits with respect
to vial fill levels.
VOLUME OF PRODUCT IN COMMERCE 12
trays of 10 vials each = 120 vials
DISTRIBUTION IL, MA,
and TX