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