SEPTEMBER 2007
WEEK ENDING SEPTEMBER 1
PRODUCT DG
Guarantee brand PMS Formula, Acetaminophen 500 mg, Pamabrom 25 mg, Pyrilamine
maleate 15 mg, 32 CAPLETS bottles, Multi-Symptom Maximum Strength (Premenstrual
Symptom Reliever), UPC # 50844 36927
CODE Lots: P40623 (exp. date 5/08), P41407
(exp. date 6/08), P41433 (exp. date 6/08), P41434 (exp. date 6/08), P41764 (exp.
date 7/08), P42322 (exp. date 9/08), P42323 (exp. date 9/08), P42425 (exp. date
9/08), P42690 (exp. date 9/08), P42691 (exp. date 9/08), P43379 (exp. date
11/08), P44022 (exp. date 1/09), P44426 (exp. date 2/09), P44778 (exp. date
2/09), P44860 (exp. date 3/09), P44861 (exp. date 3/09), P45752 (exp. date
5/09), P45753 (exp. date 5/09)
RECALLING
FIRM/MANUFACTURER
LNK International, Inc., Hauppauge, NY
REASON
Mislabeled. Directions for use on bottle
incorrectly state "adults and children 12 years and over: take 2 caplets with
water, repeat every 4 hours as needed..." but should correctly state “repeat
every 6 hours”.
VOLUME OF PRODUCT IN COMMERCE 587,232
bottles of 32 caplets
DISTRIBUTION KY, VA, MS, OH, OK,
MO, IN, FL, and SC
WEEK ENDING SEPTEMBER 8
PRODUCT Caffeine
Citrated, Powder, Purified, A mixture of equal parts of Caffeine and Citric
Acid, Assay (as Caffeine).......Approx 50%, supplied in 125 gram, 500 gram, and
2.5 kg containers, CAUTION: For manufacturing or laboratory use only,
CODE
Lot #TS0225, Lot #VI1203, Lot
#UK0821
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Spectrum Laboratory Products, Inc., Gardena, CA
Manufacturer: Spectrum Chemicals and Laboratory Products, Inc., New
Brunswick, NJ.
REASON Material is subpotent.
VOLUME
OF PRODUCT IN COMMERCE 454
units
DISTRIBUTION Nationwide
PRODUCT Compounded
Colchicine Injection in glass vials, all strengths and all sizes, for IV use
only,
CODE All
lots
RECALLING FIRM/MANUFACTURER Apothecure, Inc.,
Dallas, TX
REASON Several deaths have been reported in
connection with superpotent colchicine injection compounded by ApotheCure
Inc.
VOLUME OF PRODUCT IN COMMERCE 3,536
vials
DISTRIBUTION Nationwide
PRODUCT
a)
Cocaine The Legal Alternative Energy Supplement, 8.4 FL OZ aluminum cans, UPC code: 689076418843,
b) Free
Cocaine The Legal Alternative Energy Supplement, 8.4 FL OZ aluminum cans, UPC code #689076419048,
c)
Cut Cocaine The Legal Alternative Energy Supplement; 8.4 FL OZ aluminum cans, UPC code #689076418942,
7
CODE All
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Redux Beverages, LLC, Murrieta,
CA
Manufacturer: Gluek Brewing Co.,
Cold Springs, MN.
REASON Unapproved New Drug; product's name and
certain claims rendered the product an unapproved new drug.
VOLUME OF
PRODUCT IN COMMERCE Approximately 100,416 cases/24 cans per
case
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Thyro-Tab 0.025mg, 150,000-tablet bulk drums intended for repackaging, Rx only,
b) Levothroid
(levothyroxine sodium tablets, USP), 25 mcg, 100- and 1,000-tablet bottles, RX only, NDC 0456-1320-01 (100-ct.) and NDC
0456-1320-00 (1,000-ct.),
CODE
a) Lot HA20206, Exp. Aug 2007, and Lot
HA23606, Exp. Sep 2007;
b) Lots 080647 and 080654, Exp. Aug 2007 (from bulk
lot HA20206);
Lots 090640 and 090646 (from bulk lot
HA23606)
RECALLING FIRM/MANUFACTURER Lloyd Inc of Iowa,
Shenandoah, IA
REASON Subpotent. 9
month stability.
VOLUME OF PRODUCT IN COMMERCE 3,826,958
bulk tablets; 18,798/100-tablet bottles; 1,392/1,000-tablet
bottles
DISTRIBUTION Nationwide
PRODUCT Ampicillin
and Sulbactam for Injection, USP, 3 grams equivalent to 2 g of ampicillin plus 1
g of sulbactam, Rx only 10 vials, For IM or IV use, Sterile,
CODE
Lot P1683, Exp. October
2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter,
New Providence, NJ,
Manufacturer: G.C. Hanaford
Manufacturing Company, Syracuse, NY. REASON Presence of Particulate
Matter.
VOLUME OF PRODUCT IN COMMERCE 23,650
DISTRIBUTION Nationwide
PRODUCT Springfresh
Fluoride Toothpaste, labeled ingredients include Sodium monofluorophosphate and
Glycerin. Sold in 4 package styles: packet, clear plastic tube, white opague
plastic tube and aluminum tubes; container sizes: 0.15 oz, 0.3 oz, 0.6 oz, 0.7
oz, 0.85 oz, 1.5 oz, 2.75 oz, 3 oz, 4.6 oz, 6.4 oz, 7 oz, and 3 gm. Product of
China,
CODE All
lots
RECALLING FIRM/MANUFACTURER
Recalling Firm:
American Amenities, Inc. Woodinville, WA,
Manufacturer: Suzhou Qing Xin Daily
Chemical Co., Ltd, Suzhou, China (Mainland).
REASON Toothpaste from China may contain the poisonous
chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE 51,756 cases
DISTRIBUTION Nationwide
PRODUCT Oral
Bright Fresh Fluoride Toothpaste and Toothpaste/Toothbrush combo, Fresh
Spearmint Flavor, Net Wt 6.4 oz, labeled ingredients include Sodium
Monofluorophosphate 0.8% and Diglycol,
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc.,
Carolina, PR,
Manufacturer: Goldcredit
International Enterprises, Wuxi, Jiangsu, China (Mainland).
REASON
Toothpaste from China may
contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF
PRODUCT IN COMMERCE Approximately 115,920 tubes
DISTRIBUTION PR
PRODUCT Spearmint
Fluoride Toothpaste, labeled ingredients include Sodium Monofluorophosphate,
made in China, sold as individual tubes and in kits under the following labels
and sizes: a) Tri-Leaf brand: 17g, 24g, 42g, 78g, 130g; b) Select Medical
Products brand: 24g, 43g, 77g,
CODE All lots within
expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amsino
International Inc, Pomona, CA
Manufacturer: Shanghai Whitecat Shareholding Co., Ltd,
Shanghai, China (Mainland).
REASON Toothpaste from China may contain the poisonous
chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE 61,739 cases
DISTRIBUTION Nationwide and Canada
PRODUCT Adagen (pegademase Bovine injection), 1.5 mL single dose vials, 250 units per
mL,
Sterile for intramuscular use only, NDC 57665-001-01
CODE Lot Number NA0709 Expiration Date:
10/30/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Enzon Inc, Readington, NJ,
Manufacturer:
Enzon Pharmaceuticals, Inc, South Plainfield, NJ.
REASON
Superpotent. In-vitro enzyme (6 month
stability).
VOLUME OF PRODUCT IN COMMERCE 1,060 vials
(265 packages of 4 vials each)
DISTRIBUTION TN, France
and Australia
Bodee LLC, Inc. Issues A Nationwide Recall of All Zencore Tabs
Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, is recalling the company's supplement product sold under the name Zencore Tabs.
Bodee LLC is conducting this recall because samples found the product contains potentially harmful, undeclared ingredients.
Zencore Tabs is sold in health food stores and by mail order nationwide and in Canada. The Zencore 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.
WEEK ENDING SEPTEMBER 15
PRODUCT
a)
Azithromycin, 250 mg, 30 tablets bottle, Rx only, NDC 50111-787-10,
b) Azithromycin Tablets, 500 mg,
30 tablets bottles, Rx only, Inc.,
NDC 50111-788-10,
c) Azithromycin Tablets, 600 mg, 30 Tablets bottle, Rx
only, NDC 50111-789-10,
CODE
a) Lot numbers: 337115A, 330125A,
361125A, 214056B, 315086A,313086B, 312106A, 318106A,
700524, 303174;
b) Lot numbers: 224106A,401126A, 323125B, 356016A, 241046A,
213056B, 282086A, 284086C, 700523;
c) Lot numbers:
316086A, 338125B, 339125B, 340125B, 700549
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Pliva, Inc., East Hanover,
NJ
Manufacturer: Pliva Croatia, Ltd., Zabreb, Croatia.
REASON
Failed Impurity
Specification (15 month stability).
VOLUME OF PRODUCT IN
COMMERCE 211,256 bottles of 30 tablets
each
DISTRIBUTION Nationwide
PRODUCT
a) A-Methapred, Methylprednisolone Sodium Succinate for Injection,
USP, Sterile Powder for Injection, 40 mg Methylprednisolone Activity/mL (when mixed), single-dose vials, 10 vials per
carton, 10 cartons per shipper,
NDC 0409-3217-05, RX.
b) A-Methapred, Methylprednisolone Sodium Succinate for
Injection, USP Sterile Powder for Injection, 125 mg
Methylprednisolone Activity/2 mL (when mixed),
single-dose vials, 10 vials per carton, 10 cartons per shipper, NDC 0409-3218-05, Rx,
CODE
a) Lot # 44-085-DD, Exp. 2-1-08;
45-005-DD, Exp. 3-1-08; 45-010-DD, Exp. 3-1-08;
45-035-DD, Exp. 3-1-08; 45-410-DD, Exp. 3-1-08; 46-495-DD, Exp. 4-1-08; 46-505-DD, Exp. 4-1-08; 47-455-DD, Exp. 5-1-08;
47-456-DD, Exp. 5-1-08; 47-510-DD, Exp. 5-1-08;
48-480-DD, Exp. 6-1-08; 48-485-DD, Exp. 6-1-08;
48-486-DD, Exp. 6-1-08; 51-025-DD, Exp. 9-1-08; 51-030-DD, Exp. 9-1-08; 51-035-DD, Exp. 9-1-08;
b) Lot # 45-015-DD, Exp.
3-1-08; 45-420-DD, Exp. 3-1-08; 45-425-DD, Exp. 3-1-08; 45-470-DD, Exp. 3-1-08; 45-480-DD, Exp. 3-1-08;
47-005-DD, Exp. 5-1-08; 47-010-DD, Exp. 5-1-08;
47-015-DD, Exp. 5-1-08; 47-460-DD, Exp. 5-1-08;
47-465-DD, Exp. 5-1-08; 48-490-DD, Exp. 6-1-08; 48-495-DD, Exp.
6-1-08; 48-505-DD, Exp. 6-1-08; 48-506-DD, Exp. 6-1-08;
49-440-DD, Exp. 7-1-08; 49-441-DD, Exp. 7-1-08;
51-040-DD, Exp. 9-1-08; 51-045-DD, Exp. 9-1-08;
51-530-DD, Exp. 9-1-08; 51-615-DD, Exp. 9-1-08; 51-620-DD, Exp. 9-1-08; 51-625-DD, Exp. 9-1-08; 51-630-DD, Exp. 9-1-08;
51-715-DD, Exp. 9-1-08; 53-020-DD, Exp. 11-1-08;
53-525-DD, Exp. 11-1-08; 53-530-DD, Exp. 11-1-08;
53-535-DD, Exp. 11-1-08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake
Forest, IL
Manufacturer: Hospira Inc.,
Mc Pherson, KS.
REASON Product exceeded impurity specification
during stability testing.
VOLUME OF PRODUCT IN
COMMERCE 534,760/40 mg vials; 1,516,010/125
mg/vials
DISTRIBUTION Nationwide
WEEK ENDING SEPTEMBER 22
PRODUCT Fluoride
Toothpaste, AmerFresh and Pacific labels, packaged in whicte opaque or clear
plastic tubes, labeled ingredients include odium monofluorophosphate. Sold in
three varieties: white paste, clear gel and red gel; container sizes: 0.6 oz,
0.85 oz, 1.5 oz, 2.75 oz, 3 oz and 3 grams. Sold separately or in hygiene kits.
Made in China.
CODE All
lots
RECALLING FIRM/MANUFACTURER Phoenix Trading, Inc.,
Woodinville, WA
REASON Toothpaste from China contains the
poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE 1,257,701 tubes various sizes; 262,493 kits with
toothpaste
DISTRIBUTION Nationwide
PRODUCT DentFresh
Fluoride Toothpaste, Mint Flavor, 9 oz tubes, labeled ingredients include Sodium
Monofluorophosphate and Glycerin. Made in China.
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Dent Fresh USA, Inc.,
Miami, FL
Manufacturer: Suzhou City Jinmaco Daily Chemicals Co.
REASON
Toothpaste from China may
contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF
PRODUCT IN COMMERCE 126,000
tubes
DISTRIBUTION FL and Haiti
WEEK ENDING SEPTEMBER 29
PRODUCT
a)
DentaPro Cavity Fighting Fluoride Toothpaste, Spearmint flavor, 6.4 oz
tubes, labeled ingredients include Sodium
monofluorophosphate 0.8% and Diglycol. Made in China,
Item #9112,
b) BrightMax Fluoride Toothpaste, 6.4 oz
tubes. Made in China. Item #9111,
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Donnamax Inc., Brooklyn, NY,
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China
(Mainland).
REASON Toothpaste from China contains the poisonous
chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE 185 cases
DISTRIBUTION NY, PA, MA,
MI, OH, IL, MS, SC, GA, FL, ID
PRODUCT Product
is labeled as Goldline Genebs Extra Strength Caplets 500 mg Pain Reliever/Fever
Reducer. 1000 caplets,
CODE Lot No.
6G024
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAAX
Pharmaceuticals, Miami, FL
Manufacturer: Kirk
Pharmaceuticals, Inc., Fort Lauderdale, FL.
REASON Foreign capsule found in a 1000 count
bottle of Acetaminophen (APAP) 500 mg.
VOLUME OF PRODUCT IN
COMMERCE 4,620
bottles
DISTRIBUTION Nationwide