Talon Compounding Pharmacy (TCP) is voluntarily recalling all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to the 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 10 ml 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.
The recall does not pertain to any other medication prepared by TCP or to any other form of HCG/sermorelin (oral tablets).
This recall is being conducted with the knowledge of and in cooperation with the FDA.
List of products to be 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
Click here to read the original press release on the FDA’s website.