Innoveix Pharmaceuticals, Inc. recently voluntarily recalled lots of sterile compounded drug products. Semorelin/ Ipamorelin 3mg and injectable AOD-9604 3mg were the products that were recalled from specific Lots. These products were not sterile—when intended to be sterile. Having non-sterile products could lead to life-threatening infections. These products were distributed nationwide to customers and medical facilities. Since the recall, there has been no reports of patients getting infections.
The Identifier Software will ensure quality. Defects will be tracked and recorded in a storage database. The system requires sign offs when data is imported or changed—ensuring data integrity and quality assurance. The notion of having a double checker holds inspectors accountable for their work. Data can not be altered without a trace back to the inspector falsifying their work. Our paperless data management software will give manufacturers, FDA and pharmaceutical companies the ability pull recalls quickly and locate where defects were manufactured from. The Identifier software supports the suggested workflow from CFR 11, USP <790> and <1790>.