January 25, 2017
Town and Country Compounding and Consultation Services, LLC, is recalling more than 100 vials of HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, according to the latest US Food and Drug Administration Drug Enforcement Report (January 25, 2017).
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The company initiated the recall on October 18, 2016 due to failed potency test results of 74% (spec. 80-125%).
Human Chorionic Gonadotropin is a polypeptide hormone produced by the human placenta composed of an alpha and beta sub-unit. Chorionic Gonadotropin injection has different indications based on the gender of patients. For men and adolescent boys, it can help with the production of testosterone and sperm, while in women it can increase chances of pregnancy when used in combination with other fertility drugs.
Affected products were distributed throughout the United States. The only known lot number is for 05272016@17. On January 19, 2017, The US Food and Drug Administration designated the recall a class III, meaning that exposure to the drug is unlikely to cause adverse health consequences—Sean McGuire.
Enforcement Report. US Food and Drug Administration Website. http://www.accessdata.fda.gov/scripts/ires/index.cfm. Published January 25, 2017 Accessed January 25, 2017.