- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionDue to Lack of Sterility Assurance
- Company Name:
- Synergy Rx Pharmacy
- Brand Name:
Brand Name(s)Synergy Rx Pharmacy
- Product Description:
Product DescriptionHuman Chorionic Gonadotropin (HCG)for injection
Synergy Rx Pharmacy is voluntarily recalling 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.
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Synergy Rx Pharmacy has not received any reports of adverse events, to date, related to this recall.
Human Chorionic Gonadotropin (HCG) is an unapproved product being marketed as 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. 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.
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. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Synergy Rx Pharmacy deeply regrets any disruption that this voluntary recall of HCG (Human Chorionic Gonadotropin) Sterile compounding services have on its customers, but notes that safety and quality are its primary concerns.
Link to Expanded Recall.