Balanced Products recall

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Balanced Health Products, Inc. Conducts 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* -- November 24, 2008--- Balanced Health Products,

Inc. is voluntarily recalling *STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot

12/2011 – 84810*, sold in 30 capsule plastic bottles.

The recall is effective immediately and is being undertaken because this lot

of STARCAPS contains 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.

To date, this recall only applies to *Lot 12/2011 – 84810*. The company is

in the process of testing other lots and will notify the FDA of its results,

as well as, if additional lots are to be recalled.

The recalled lot totaling 1,974 consumer-size bottles were distributed

nationwide from August 2008 to October 30, 2008 through retail outlets and

online sales.

Consumers who purchased *STARCAPS Lot 12/2011 – 84810* 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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