MAY 2008

WEEK ENDING MAY 3

"Total Body Formula" and "Total Body Mega Formula" Products

The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has recalled certain flavors of "Total Body Formula" and "Total Body Mega Formula” . The dietary supplement products contained hazardous amounts of selenium in samples of "Total Body Formula" in Tropical Orange and Peach Nectar flavors and "Total Body Mega Formula" in the Orange/Tangerine flavor. Further analysis of the products found high levels of chromium as well. 

Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.

There were confirmed cases of adverse reactions in consumers using the products which has climbed to at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.

Consumers were first cautioned March 27, 2008 not to purchase and to discontinue the use of "Total Body Formula" in Tropical Orange and Peach Nectar flavors and "Total Body Mega Formula" in the Orange/Tangerine flavor after receiving reports of adverse reactions.

PRODUCT Atenolol and Chlorthalidone tablets, USP, 50/25 mg, bottles of 100, Rx only, NDC 0904-7881-60, 
CODE Lot L-1456, Exp. 08-09
RECALLING FIRM/MANUFACTURER Legacy Pharmaceutical Packaging LLC, Earth City, MO,
REASON Mislabeled; bottles labeled as Atenolo/Chlorthalidone Tablets 50mg/25mg actually contain Gabapentin 100 mg.
VOLUME OF PRODUCT IN COMMERCE 4,778/100-tablet bottles
DISTRIBUTION MI

PRODUCT Etomidate Injection 20mg (2mg/mL), Sterile, nonpyrogenic, 10mL Single-Dose Vials, packaged in cartons of 10 vials, --- NDC 55390-762-10, 
CODE Lot #957881, Exp. Date 06/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bedford Laboratories, Bedford, OH, 
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. 
REASON Subpotent; 12month stability
VOLUME OF PRODUCT IN COMMERCE 97,290 20mg/10mL vials
DISTRIBUTION Nationwide

PRODUCT Carbamazepine Tablets USP (Chewable), 100 mg, Rx, in bottles of 100 Tablets, NDC 51672-4041-1, and 500 Tablets, NDC 51672-4041-2, 
CODE Lots 078198, 078335, 078336 (exp. 7/2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, 
Manufacturer: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel, 
REASON Failed USP Dissolution Test Requirement.
VOLUME OF PRODUCT IN COMMERCE 26,008 bottles
DISTRIBUTION Nationwide and Puerto Rico

PRODUCT Red Yeast Rice, Dietary Supplement, 600 mg potency, 60-capsule bottles, UPC 033674155172 and 120-capsule bottles, UPC 033674155400, 
CODE 60-Capsule Bottles: Lots 509859, exp. 10/31/08; 514596, exp. 1/31/09; 522011, exp. 5/31/09; 528163, exp. 10/31/09; 530491, exp. 11/30/09; 120-Capsule Bottles: Lots 504570, exp. 6/30/08; 507169, exp. 8/31/08; 511280, exp. 10/31/08; 514341, exp. 1/31/09; 518847, exp. 1/31/09; 520928, exp. 4/30/09; 524941, exp. 8/31/09; 525251, exp. 8/31/09; 528162, exp. 10/31/09; 531608, exp. 11/30/09
RECALLING FIRM/MANUFACTURER Nature's Way Products Inc., Springville Utah, 
REASON Product contains excessive levels of lovastatin.
VOLUME OF PRODUCT IN COMMERCE 74,859 bottles
DISTRIBUTION Nationwide

Hydrox Labs Issued a Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health

Hydrox Labs, Elgin, IL has issued a recall of Cardinal Health labeled alcohol-free mouthwash.  As a result of this recall, Cardinal Health is initiating a recall of the same alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia).  

Product was distributed to hospitals, medical centers, and long term care facilities nationwide.

The recall includes the following products:

Product lot number 26228 is affected.  Affected product can be identified by checking the lot code stamped on the Cardinal Health label.  The Lot number is located on the side of the bottle. 

The mouthwash may also be found in certain Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Cardinal Health from your healthcare provider, please check to see if the reorder number on the label matches the recalled reorder numbers listed above, then check to see if the lot number matches the recalled lot number.

Customers who have Cardinal Health labeled alcohol free mouthwash which is being recalled should stop using the product and contact Cardinal Health for instructions.

Cardinal Health is notifying their customers via overnight mail and is arranging for all product to be returned for credit.

WEEK ENDING MAY 10

PRODUCT Zomig (zolmitriptan) tablets, 2.5 mg, unit-dose blister package containing 6 tablets per carton, Rx only, NDC 0310-0210-20, 
CODE Lot 106033, exp. August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astra Zeneca, Wilmington, DE, 
Manufacturer: IPR Pharmaceuticals, Inc., Carolina, PR. 
REASON Some blister cells may not contain product.
VOLUME OF PRODUCT IN COMMERCE 44,028 blister packs
DISTRIBUTION Nationwide and Hawaii

WEEK ENDING MAY 17

PRODUCT BP Balance AF (Enhanced BP Balance), Original Chinese formula, Herbal supplement, 250 milligram Vegetarian Caplets, 100 count and 200 count bottles, 
CODE There are no codes or lot numbers assigned to these products.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Geromatrix Health Products, Boca Raton, FL, 
Manufacturer: Active Nutraceuticals, Carrollton, GA. 
REASON Unapproved New Drug; product contains undeclared promethazine.
VOLUME OF PRODUCT IN COMMERCE 185 containers of 100 count.
DISTRIBUTION Nationwide

PRODUCT
a)  Schwarz Pharma Neupro (rotigotine transdermal system) 2 mg/24 hours, Rx, 7 systems (NDC 0091-6486-21); 30 systems (NDC 0091-6486-01); and PROFESSIONAL SAMPLES - Not for sale, 
b) Schwarz Pharma Neupro (rotigotine transdermal system); 4 mg/24 hours, Rx, 7 systems (NDC 0091-6487-21); 30 systems (NDC 0091-6487-01); and PROFESSIONAL SAMPLES - Not for sale, 
c) Schwarz Pharma Neupro (rotigotine transdermal system); 6 mg/24 hours, Rx, 7 systems (NDC 0091-6488-21); 30 systems (NDC 0091-6487-01); and PROFESSIONAL SAMPLES - Not for sale, 
d) Schwarz Pharma Neupro Titration Kits (rotigotine transdermal system); Kits contain:  7 patches, 2 mg/24 hours, -7 patches, 4 mg/24 hours, -7 patches, 6 mg/24 hours, Rx only, NDC 0091-6480-99, 
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schwarz Pharma Manufacturing, Seymour, IN, 
Manufacturer: Lohmann Thereapie-Systeme AG, Andernach, Germany. 
REASON Crystallization; active ingredient is forming crystals, which may result in a lower dose being delivered.
VOLUME OF PRODUCT IN COMMERCE 1,090,814 packages
DISTRIBUTION Nationwide

PRODUCT InVite brand Yeast Rice Extract, Herbal Support For Cholesterol Levels Already Within a Normal Range, 600 mg, Dietary Supplement, 120 capsules, UPC 6 66782 50525 8, 
CODE Lots: 0710106 (exp. 10/2010) and 0704020 (04/2010)
RECALLING FIRM/MANUFACTURER Bactolac Pharmaceutical, Inc., Hauppauge, NY
REASON Unapproved New Drug; product found to contain Lovastatin, the active pharmaceutical ingredient in Mevacor.
VOLUME OF PRODUCT IN COMMERCE 2247 bottles
DISTRIBUTION NY and NJ

Medicis Announces Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up

  Medicis is recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN® (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg. AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients. Side effects associated with the use of AZASAN®, particularly in the elderly, include mylosuppression (decrease in the number of red and white blood cells and platelets), infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Unanticipated interactions with other drugs may also lead to serious adverse events. SOLODYN® is manufactured by AAIPharma, Inc. under contract to Medicis. The two lots were manufactured during February 2008. The recall is limited to these lots, and ample supplies of SOLODYN® remain on the market.

Any inquiries related to this recall should be addressed to Stericycle Customer Service at 1-888-656-6381 with representatives available Monday through Friday, 8 a.m. to 11 p.m. EST. For any medical information inquiries or to report an adverse event related to this recall, contact Medicis at 1-800-900-6389 with representatives available 24 hours a day, 7 days a week.

Hydrox Labs Issued a Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health

Hydrox Labs, Elgin, IL has issued a recall of Cardinal Health labeled alcohol-free mouthwash. As a result of this recall, Cardinal Health is initiating a sub recall of this lot of alcohol-free mouthwash. The mouthwash was tested, and certain samples were found positive for Burkholderia cepacia (B. cepacia).

Product was distributed to hospitals, medical centers, and long term care facilities nationwide.

The recall includes the following products:

Affected product can be identified by checking the lot number stamped on the Cardinal Health label. The Lot number is located on the side of the bottle.

The mouthwash may be found in certain Personal Hygiene Hospital Admission Kits. If you received Cardinal Health labeled alcohol-free mouthwash from your healthcare provider, please compare the Cardinal Health reorder number on the upper left corner of the product label with the recalled reorder number above, then check to see if the lot number at the bottom of the label matches the recalled lot number.

Customers who have Cardinal Health labeled alcohol free mouthwash being recalled should stop using the product and contact Cardinal Health at the number above for instructions.

Cardinal Health is notifying their customers via overnight mail and is arranging for all product to be returned for credit.

WEEK ENDING MAY 24

PRODUCT
a) Intralipid 10%, a 10% Fat Emulsion for Intravenous Use, 500 mL flexible plastic container, sterile, Rx only, each 100 mL contains Soybean Oil 10 g, Phospholipids 1.2 g, Glycerin USP 2.25 g, NDC 0338-0518-13, Product code 2B601,  
b) 

1) Intralipid 20%, a 20% Fat Emulsion for Intravenous Use, 100, 250, 500 mL  flexible plastic containers, sterile, Rx only, each 100 mL contains Soybean Oil 20 g,  Phospholipids 1.2 g, Glycerin USP 2.25 g, NDC 0338-0519-02, 0338-0519-03, 0338- 0519-48, 1) Product code 2B6030: 

2) Product code 2B6022: 

3) Product code 2B6023:  

4) Product code JB6023 (sold in Canada only), 
c) Intralipid 30%, a 30% Fat Emulsion for Intravenous Use, 500 mL flexible plastic container, Pharmacy Bulk Package, sterile, Rx only, each 100 mL contains Soybean Oil 30 g, Phospholipids 1.2 g, Glycerin USP 1.7 g, NDC 0338-0520-03, Product code 2B6053,
CODE
a) Lots WB11179, exp. 1/31/09; WD12411, 3/31/09;
b) 1) Lots WB11032, exp. 1/31/09; WB11034, exp. 1/31/09; WB11163, exp. 1/31/09;  WC11686, 2/28/09, WC11688, exp. 2/28/09; WC11690, exp. 2/28/09; WD12645,  exp. 3/31/09; WD12649, exp. 3/31/09; WD12647, exp. 3/31/09; WE13167, exp. 4/30/09; WE13169, exp. 4/30/09; WE13248, exp. 4/40/09; WE13385, exp. 4/30/09;  2) Lots WC11968, exp. 2/28/09; WD12368, exp. 3/31/09; 3) Lots WB11318, exp. 1/31/09; WB11410, exp. 1/31/09; WC11699, exp. 2/28/09; 4) Lot WD12723;
c) Lot WE13010, exp. 4/30/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, 
Manufacturer: Fresenius Kabi, Uppsala, Sweden. 
REASON There is an increased potential for port splitting to occur in the administration port.
VOLUME OF PRODUCT IN COMMERCE 235,140 units
DISTRIBUTION Nationwide and Canada

PRODUCT Terbutaline Sulfate Injection USP 1 mg/ml, 25 - 1mL Single Use Vial, For Subcutaneous Injection, Rx Only, NDC number 0703-1271-04, 
CODE Lot numbers 06K128 exp 8/2008 and 07B121 exp 2/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. 
REASON Exceeded Specification for pH (18 month stability)
VOLUME OF PRODUCT IN COMMERCE 152,525 vials
DISTRIBUTION Nationwide

WEEK ENDING  MAY 31

Xiadafil VIP Tabs
Product contains undeclared ingredient that puts consumer health at risk

SEI Pharmaceuticals, of Miami, Fla., is recalling all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED).

This undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions.

Consumers who have used this product should discontinue use immediately and consult their health care professional if they have experienced any adverse events that they believe may be related to the use of this product.

PRODUCT ZANTAC 75 (Ranitidine) Tablets 75 mg, 1 Tablet (1 dose), Acid Reducer, 
CODE Lot #A14991, Expiration Date: 12/2008
RECALLING FIRM/MANUFACTURER
 Recalling Firm: Boehringer Ingelheim Roxane Inc., Columbus, OH, 
Manufacturer: DSM Pharmaceuticals Inc., Greenville, SC. 
REASON Exceeded Impurities Specification: (S-oxide)
VOLUME OF PRODUCT IN COMMERCE 2,279,200 tablets
DISTRIBUTION Nationwide

PRODUCT AMIODARONE HCl Injection, 150mg/3mL (50mg/mL), 10 Single Use Vials, FOR IV USE ONLY, MUST BE DILUTED, Rx ONLY, 
CODE Lot #1156947, Expiration Date: 12/09
RECALLING FIRM/MANUFACTURER Ben Venue Laboratories Inc, Bedford, OH,
REASON Presence of Particulate Matter; vials contained crystallized active ingredient.
VOLUME OF PRODUCT IN COMMERCE 15,327 packs - 10 vials per pack (153,270 vials)
DISTRIBUTION Nationwide

International Pharmaceuticals, Ltd. Issues a Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement

International Pharmaceuticals, Ltd., P.O. Box 5165, Bradford, MA 01835, announced a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.

International Pharmaceuticals, Ltd. is conducting this recall after being informed that lab analysis of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil.  The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.

VIP Tabs are sold in retail outlets nationwide and are packaged into 2-capsule blister packs and 8-capsule bottles.

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 portions be returned to CB Distributors in Benoit, Wisconsin, in accordance with return instructions/questions obtained by calling (800)-273-4137, Ext. 3.