Talon Compounding Pharmacy (“TCP”) of San Antonio, Texas, is voluntarily recalling all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to the Food and Drug Administration’s (“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 used for a variety of indications. 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 vials were shipped in zippered plastic bags bearing the patient name, date, directions for use, prescription number, lot number of dispensed medication, beyond-use date, vial size, prescriber name, and pharmacy name, address, phone number and logo. Please see attached photo for an example of what a recalled vial may have looked like. The recall does not pertain to any other medication prepared by TCP or to any other form of HCG/sermorelin (oral tablets).
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. TCP takes the utmost care to ensure patient safety and out of an abundance of caution 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]. 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.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of and in cooperation with the FDA.
Again, TCP’s primary concern is your safety, and TCP is taking this action out of an abundance of caution. Thank you for your support.
List of products recalled
Unused or in-use vials of lyophilized HCG in any strength
Unused or in-use vials of lyophilized HCG with B12 in any strength
Unused or in-use vials of lyophilized sermorelin of any strength