Home / Recalls / Pharmakon Pharmaceuticals, Inc. / D-1293-2016

D-1293-2016 Class II Terminated

Recalled by Pharmakon Pharmaceuticals, Inc. — Noblesville, IN

Recall Details

Product Type: Drugs
Report Date: July 20, 2016
Initiation Date: April 20, 2016
Termination Date: January 11, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 100

Product Description

HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Code Information

All Sterile Compounded Products within Expiry

Other recalls by Pharmakon Pharmaceuticals, Inc.

D-1275-2016 Class II — Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun (April 20, 2016)
D-1291-2016 Class II — Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject (April 20, 2016)
D-1276-2016 Class II — Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun (April 20, 2016)
D-1329-2016 Class II — Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerl (April 20, 2016)
D-1339-2016 Class II — Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMA (April 20, 2016)
D-1258-2016 Class II — Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride (April 20, 2016)
D-1325-2016 Class II — HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject (April 20, 2016)
D-1266-2016 Class II — Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compoun (April 20, 2016)
D-1320-2016 Class II — Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL (April 20, 2016)
D-1326-2016 Class II — HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoje (April 20, 2016)