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Compounded HCG and Sermorelin Recalled for Lack of Sterility Assurance


On July 21, 2016, Talon Compounding Pharmacy voluntarily recalled all lots of lyophilized HCG (Human Chorionic Gonadotropin; to stimulate secretion of estrogen and progesterone or ovulation) and sermorelin (growth hormone involving aging) aseptically compounded and packaged by TCP and that remain within expiry due to FDA concern over a lack of sterility assurance. Although no complaints of illness or injury have been received regarding the recalled lots, administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.

 

The sterile products were distributed to patients and providers nationwide between January 18 and July 18, 2016. The recalled lots were packaged in 10ml amber glass vials bearing a label containing the name and strength of the drug, the lot number and the beyond-use date. The list of products to be recalled include unused or in-use vials of lyophilized HCG in any strength, unused or in-use vials of lyophilized HCG with B12 in any strength, and unused or in-use vials of lyophilized sermorelin of any strength.

 

Though no vial or portion of any lot of these medications has been found to be non-sterile, because the process of lyophilizing HCG and sermorelin has not been verified, patients may be at risk. Talon is asking all patients and providers that received lyophilized HCG and sermorelin compounded products from TCP between January 18 and July 18, 2016, and that remain within expiry, to take the following actions: Discontinue use of the products, contact the company and quarantine any unused product until further instructions are received on how to return the product.

 

See the FDA Safety Alert

 

Also see the Recall

 

See also Medical Law Perspectives, February 2016 Report: Problematic Procreation: Liability Risks in Diagnosing and Treating Infertility

 

See also Medical Law Perspectives, August 2015 Report: Pediatrician Liability Involving Diseases and Conditions of Childhood

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication 

 

 

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