Home / Recalls / Pharmakon Pharmaceuticals, Inc. / D-1344-2016

D-1344-2016 Class II Terminated

Recalled by Pharmakon Pharmaceuticals, Inc. — Noblesville, IN

FDA drug recall D-1344-2016 was initiated by Pharmakon Pharmaceuticals, Inc. on April 20, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated January 11, 2018). Affected quantity: 595.

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: 595

Product Description

Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 mL Intravia Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN, NDC 45183-0996-02

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-1266-2016 Class II — Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compoun (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-1287-2016 Class II — Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Comp (April 20, 2016)
D-1296-2016 Class II — Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compo (April 20, 2016)
D-1312-2016 Class II — Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ON (April 20, 2016)
D-1340-2016 Class II — Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe, Rx Only, Compounded by PHA (April 20, 2016)
D-1293-2016 Class II — HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Com (April 20, 2016)
D-1308-2016 Class II — Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 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)