Home / Recalls / Pharmakon Pharmaceuticals, Inc. / D-1306-2016

D-1306-2016 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: 50

Product Description

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02

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-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-1330-2016 Class II — Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compou (April 20, 2016)
D-1322-2016 Class II — Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHAR (April 20, 2016)
D-1319-2016 Class II — Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 (April 20, 2016)
D-1331-2016 Class II — Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compo (April 20, 2016)
D-1267-2016 Class II — Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmac (April 20, 2016)
D-1309-2016 Class II — Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by (April 20, 2016)
D-1284-2016 Class II — Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), (April 20, 2016)
D-1337-2016 Class II — Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharma (April 20, 2016)
D-1280-2016 Class II — Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by (April 20, 2016)