HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance

AUDIENCE: Patient, Pharmacy

ISSUE: Talon Compounding Pharmacy (TCP) voluntarily recalled all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to FDA concern over a lack of sterility assurance. 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.

BACKGROUND: 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.

RECOMMENDATION: Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. Providers who have dispensed any lyophilized HCG or sermorelin to a patient(s) for use outside of the provider's office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall. 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;
•             Quarantine any unused product until further instructions are received on how to return the product; and
•             Contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at [email protected] to discuss the return of any unused lyophilized HCG and/or sermorelin.

Customers with questions regarding this recall can contact TCP at 830-816-5910 from the hours of 8:30AM – 5:00PM central time Monday – Friday, or e-mail at [email protected].

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

•             Complete and submit the report Online: www.fda.gov/MedWatch/report
•             Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm512729.htm