PD-Rx Pharmaceuticals, Inc.

FDA Class II Recall: PD-Rx Pharmaceuticals' Duloxetine Contaminated with N-Nitroso-Duloxetine

PD-Rx Pharmaceuticals, Inc. initiated a Class II recall for 70 bottles of Duloxetine DR USP 30 mg due to N-Nitroso-Duloxetine, an NDSRI, exceeding acceptable limits. This CGMP deviation highlights critical quality control failures. Procurement and regulatory teams must scrutinize current supply chains for similar nitrosamine risks and verify supplier compliance to safeguard product integrity and patient safety.