The company voluntarily recalls all lots of lyophilized HCG and sermorelin.
Talon Compounding Pharmacy (San Antonio, TX) announced on July 21, 2016 that it was recalling all lots of lyophilized HCG and sermorelin because of a lack of sterility assurance. The affected lots were distributed nationwide between January 18 and July 18, 2016.
Although the company reports it has not yet received any complaints of illness or injury, administration of compromised sterile products can cause serious infections and/or other complications. The company states that the recalled lots, which were packaged in 10 mL amber vials, have not been found to be non-sterile; however, patients may be at risk because the process of lyophilizing HCG and sermorelin has not been verified. The recall does not apply to other forms of HCG/sermorelin, such as oral tablets.
Patients and providers are advised to discontinue use of the product and quarantine any unused product. Adverse events can be reported to FDA atwww.fda.gov/medwatch/report.htm.