Concerns about sterility of an unapproved weight loss treatment have prompted Synergy Rx Pharmacy to recall all lots of Human Chorionic Gonadotropin (HCG). Administration of a drug intended to be sterile that is not could result in serious infections that could be life threatening. To date, Synergy Rx Pharmacy has not received any reports of adverse events related to this recall.
HCG is a hormone produced by the human placenta and found in the urine of pregnant women. It is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. The products are only available in injection form and require a prescription from a licensed medical professional. There are no FDA-approved HCG products for weight loss as the hormone has not been demonstrated to be effective in the treatment of obesity nor is there substantial evidence that HCG increases weight loss, the FDA warned.
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued at least seven joint warning letters to companies marketing over-the-counter HCG drugs that are labeled as homeopathic for weight loss because selling these unapproved and misbranded drugs that make substantial claims is in violation of federal laws.
The Synergy Rx Pharmacy recall of HCG involves 5,000 units/vial and 11,000 units/vial packaged in 15 mL serum glass vials bearing a label that includes Synergy Rx Pharmacy’s name and expiration date. All lots of these products are affected and were distributed between June 1, 2016, and Dec. 22, 2016, to physician offices and clinics in Arizona, California, Wisconsin and Minnesota.
Synergy Rx Pharmacy is currently notifying its customers of the recall and arranging for the return of the products. Customers who experience any problems that may be related to use of this product should contact their doctor. Any adverse events or side effects should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.