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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance
AUDIENCE: Consumer
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 and is arranging for return of all recalled products. Customers that have the recalled product should immediately stop using it and contact the help line to arrange for the return of any unused product.
Customers with questions regarding this recall can contact Synergy Rx Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm Pacific Time Zone, at 619-821-8224.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release, at:
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