| U.S. Food and Drug Administration |
FDA Press Release, Dec 8, 2008
Balanced Health Products, Inc. Expands Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient
FOR IMMEDIATE RELEASE -- December 8, 2008 -- Balanced Health
Products, Inc. has expanded its voluntary recall of STARCAPS DIET
SYSTEM DIETARY SUPPLEMENT to include additional Lot Numbers 12/2009 – 82866 and
12/2010 - 83801, sold in 30 capsule plastic bottles.
The recall is effective immediately and is being undertaken because these
lots of STARCAPS contain an undeclared drug ingredient- Bumetanide – a diuretic
available by prescription only. Bumetanide is also not listed on the product
label as an ingredient in this product.
Bumetanide is a diuretic indicated for the treatment of edema associated with
congestive heart failure, hepatic and renal disease including nephrotic
syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per
capsule. Potential risks associated with the use of Bumetanide include serious
and significant fluid and electrolyte loss and an elevation in uric acid
concentrations. Consumers should not take Bumetanide if they are allergic to
sulfonamides. Significant drug interactions with Bumetanide, such as with
digoxin and lithium, may lead to an increase risk of toxicity. Patients may also
be at an increased risk of hypotension (low blood pressure), fainting (syncope)
and resultant injury if they have normal blood pressure or are already taking an
antihypertensive medication and take STARCAPS with undeclared Bumetanide.
The company has received no reports of illness associated with this product.
The company’s investigation to date has indicated that an additional lot of
raw material intended for use in the production of STARCAPS which has been
stored in sealed drums since the time of its importation into the U.S. is also
contaminated with Bumetanide. This information seems to indicate that the
contamination occurred at the point of production of the raw material in Lima,
Peru.
STARCAPS lot number 12/2009 – 82866,
totaling 28,739 consumer-size bottles was distributed nationwide from
3/2006 to 4/2007 through retail outlets and online sales.
STARCAPS lot number 12/2010 - 83801,
totaling 28,530 consumer-size bottles was distributed nationwide from
5/2007 to 7/2008 through retail outlets and online sales.
Consumers who purchased STARCAPS Lot Numbers 12/2009 – 82866 and
12/2010 – 83801 should immediately discontinue their use and return it
to Balanced Health Products, Inc. at the address on the product label.
Consumers with questions may contact the company at (212) 794-9793 from
10:30am to 4pm EST Monday through Friday.
Consumers who experience adverse events with any lots of this product should
seek immediate help from their physician or healthcare provider.
Retail stores are being notified by fax or registered mail to immediately
stop all sales and return product to the company.
This recall is being made in cooperation with the US Food and Drug
Administration.
Any adverse reactions experienced with the use of this product should also be
reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at
1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville,
MD 20852-9787
This advisory was prepared by the FDA Office of Public Affairs.