Expansion of Starcaps Recall

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Balanced Health Products, Inc. Expands Voluntary Urgent Nationwide Recall of

Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug

Ingredient

*Contact:*

Balanced Health Products

(212)794-9793

*FOR IMMEDIATE RELEASE* -- December 8, 2008 -- Balanced Health Products,

Inc. has expanded its voluntarily 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 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, or on the MedWatch website at *

wwww.fda.gov/medwatch <https://www.accessdata.fda.gov/medwatch/>*.

--

Ortiz, RD

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