Recall of Human chorionic gonadotropin freeze dried vials by Synergy Rx – Lack of sterility assurance

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ISSUE: Synergy Rx Pharmacy recalled all lots of Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial to the retail level due to a lack of sterility assurance. This recall impacts all sterile products distributed between 06/01/2016 and 12/22/2016. The product was only distributed to physician offices and clinics in Arizona, California, Wisconsin, and Minnesota.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

BACKGROUND: Human Chorionic Gonadotropin (HCG) is an unapproved product marketed for weight loss. The product is 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. Synergy Rx Pharmacy has not received any reports of adverse events, to date, related to this recall.

RECOMMENDATION: Synergy Rx Pharmacy is notifying its customers by phone an...

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