Compounding Pharmacy Recalls 2 Products

FDA says that Talon Compounding Pharmacy, San Antonio, TX, is recalling all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by the pharmacy due to the agency’s concern about a lack of sterility assurance. An agency statement says that although there have been no complaints of illness or injury involving the recalled items, administration of a sterile drug intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.

The notice says the sterile products were distributed to patients and providers nationwide between 1/18 and 7/18. They were used for a variety of indications and were packaged in 10mL amber glass vials with a label containing the drug name and strength, the lot number, and the beyond-use date.

The recall does not pertain to any other medication prepared by the pharmacy or to oral tablets for HCG/sermorelin, FDA says.