Urgent Recall Issued for StarCaps Dietary Supplements

Ingredient in StarCaps Could Cause Serious Health Problems

An urgent, nationwide recall of StarCaps Dietary Supplements has been issued by the FDA and the manufacturer of the product, Balanced Health Products Inc, because the supplements have been found to contain an undeclared drug ingredient- Bumetanide. This ingredient is not listed on the product label.

Bumetanide is available by prescription only, and is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. 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 can occur with Bumetanide, such as with digoxin and lithium, and may lead to an increased 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.

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 if additional lots are to be recalled.

The recalled lot totaling 1,974 consumer-size bottles was distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales.

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Published on Nov-26-08