Talon Compounding Pharmacy (TCP) is recalling all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP due to Food and Drug Administration (FDA) concerns that the products are not sterile. Administration of a sterile drug product that has been compromised can result in health hazards including risk of serious infection or other complications.
The products were distributed to patients and providers nationwide between Jan. 18 and July 18, 2016.
Lyophilized HCG (human chorinoc gonadotropin) is a freeze-dried hormone produced by the human placenta. It is used to for prepubertal cryptorchidism, or a birth defect in which there is an absence of one or both testes from the scrotum. It is also used to treat hypogonadism, or low testosterone, due to a pituitary deficiency, and to induce ovulation and pregnancy in women who are not ovulating but wish to conceive.
Sermorelin is a growth hormone engineered to stimulate the secretion of Growth Hormone Releasing Hormone (GHRH) from the hypothalamus. It is used as a diagnostic agent to assess growth hormone secretion.
Customers who have purchased these products from TCP and have experienced any related problems should contact their doctors. Providers who have dispensed these products should notify patients and advise them of this recall.
Any side effects or adverse events related to the use of these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.