August 30, 1996

The Food and Drug Administration is announcing a nationwide alert concerning 30 milliliter vials of Hallmark Labs injectable "adrenal cortex extract," distributed by Phyne Pharmaceuticals of Scottsdale, Ariz., because this product can cause serious and life-threatening injuries.

Since April 1996, FDA, the U.S. Centers for Disease Control and Prevention and numerous state agencies have received reports of abscesses -- serious bacterial infections -- forming at sites where patients have been injected with these products. To date, at least 54 cases of these infections have been reported throughout the United States.

Adrenal cortex extract is not approved for use by FDA for any indication and is usually derived from the adrenal glands of cattle, sheep or swine. Although it has never been shown to be effective for treating any medical condition, it has been promoted over the years for a wide variety of uses including weight loss, burn treatment and lessening substance abuse addictions.

The adrenal cortex extract of concern may have been prepared under conditions that could have lead to its contamination. These products could also be improperly labeled -- containing indications for use that might expose immunocompromised patients to particular risk.

FDA has worked with other government agencies in investigating how this potentially contaminated product was manufactured and distributed. The agency is taking regulatory steps to identify the responsible parties and to ensure that these products are promptly removed from the market.

Because of the seriousness of this situation, FDA is trying to directly notify as many consignees of these products as possible.

Physicians or consumers who have adrenal cortex extract products bearing "Hallmark Labs" on the label should immediately stop using the product and contact FDA at (714) 667-7416.

Patients experiencing swelling, tenderness, other signs of infection at the site of injection or other adverse reactions should contact their physician immediately.

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