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

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

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...

Recommended for you

  • FDA Drug Updates
  • 1 comment

FDA expands approved use of Stivarga (regorafinib) for liver cancer

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Brineura (cerliponase alfa) for Batten disease

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of 25% Dextrose Injection, USP, (Infant) by Hospira- Presence of particulate matter

Read more
  • MedWatch Drug Updates
  • 1 comment

Drug safety alert: New warning on use of anesthetic/sedation drugs in young children, pregnant women

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA warning- Illegal selling of products that fraudulently claim to prevent, diagnose, treat or cure cancer

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Phenobarbital tablets, USP, 15 mg by C.O. Truxton- Mislabeling with incorrect strength

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Ingrezza (valbenazine) for tardive dyskinesia

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA restricts use of codeine and tramadol in children and breastfeeding women-Risk of serious adverse reactions

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Ocrevus (ocrelizumab) for multiple sclerosis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Zejula (niraparib) for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer

Read more
  • FDA Drug Updates
  • 1 comment

FDA approves Dupixent (dupilumab) for atopic dermatitis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Bavencio (avelumab) for Merkel cell carcinoma

Read more
  • FDA Drug Updates
  • no comment

FDA approved Xadago (safinamide) for Parkinson’s disease

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Homeopathic Baby Teething products by Hyland- Elevated levels of belladonna

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of the StrataMR adjustable valves and shunts by Medtronic- Under-drainage of CSF post-implantation

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Odactra for house dust mite allergies

Read more
  • FDA Drug Updates
  • 1 comment

Approval of Xermelo (telotristat ethyl) for carcinoid syndrome diarrhea

Read more
  • MedWatch Drug Updates
  • no comment

Recall of sterile products by Isomeric Pharmacy Solutions- Lack of sterility assurance

Read more
  • MedWatch Drug Updates
  • 1 comment

Field corrective action for Newport HT70 and HT70 Plus ventilators by Medtronic -Ventilators may reset spontaneously

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of EpiPen and EpiPen Jr Auto-Injector- Failure to activate device due to defect in a supplier component

Read more
  • FDA Drug Updates
  • no comment

FDA approves Siliq (brodalumab) for psoriasis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Parsabiv (etelcalcetide) for hyperparathyroidism in dialysis patients

Read more
  • FDA Drug Updates
  • 1 comment

FDA approval of Emflaza (deflazacort) for duchenne muscular dystrophy

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I Recall : HeartStart MRx Monitor/Defibrillator by Phillips - Electrical and battery connection issue

Read more
  • FDA Drug Updates
  • 1 comment

Approval of Trulance (plecanatide) for chronic idiopathic constipation

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA safety alert - Absorb GT1 Bioresorbable Vascular Scaffold associated with increased risk of CV events

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA Safety Alert: breast implants associated with risk of developing anaplastic large cell lymphoma

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of SynchroMed Implantable Infusion Pump by Medtronic due to hindered drug delivery during priming bolus procedure

Read more
  • FDA Drug Updates
  • 1 comment

First drug approved for treatment of spinal muscular atrophy

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Rubraca (rucaparib) for BRCA+ advanced ovarian cancer

Read more