Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68

Recall Number: D-1292-2016

Firm: Pharmakon Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20160720

Initiation Date: 20160420

Termination Date: 20180111

Lack of Assurance of Sterility

Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68