Synergy Rx Pharmacy Issues Recall Due to Lack of Sterility

February 15, 2017

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

On Feb. 14, 2017, Synergy Rx Pharmacy announced a voluntary recall of all lots of of human chorionic gonadotropin  (HCG) 5000 units/vial and 11,000 units/vial, distributed between June 1, 2016 and Dec. 22, 2016, because of a lack of sterility assurance. The recalled lots, which were packaged in 15 mL serum glass vials, were distributed to physician offices and clinics in Arizona, California, Wisconsin, and Minnesota.

As of Feb. 14, the company had not received any reports of adverse events due to the recalled product but it warns that use a product intended to be sterile that is not sterile could result in serious infections. The company is advising customers to stop use of the product and return any unused lots. Adverse events can be reported to FDA at www.fda.gov/medwatch/report.htm.

Source: FDA