Unapproved Weight Loss Injectable Recalled

Recall of Human Chorionic Gonadotropin vials occurred due to a lack of sterility assurance. The product is not approved by the FDA for any other over-the-counter indication.

Synergy Rx Pharmacy announced a recall of all lots of Human Chorionic Gonadotropin (HCG) 5,000 Units/vial and 11,000 Units/vial strengths due to a lack of sterility assurance.

The affected products were distributed between 6/1/2016 and 12/22/2016 to physician offices and clinics in Arizona, California, Wisconsin, and Minnesota. They were packaged in 15mL serum glass vials. 

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Although marketed for weight loss, HCG is not approved by the Food and Drug Administration (FDA) for this or any other over-the-counter indication. Injections of HCG have been claimed to help with weight reduction by reducing hunger and affecting mood, though very few efficacy studies have been conducted. Products that are intended to be sterile but are not may cause serious infections that could potentially be life-threatening.

To date, no adverse events have been reported related to this recall. Synergy Rx Pharmacy is informing its customers and arranging for return of all impacted products. Customers in possession of the recalled products should discontinue use immediately. 

For more information call (619) 821-8224 or visit FDA.gov.