Home / Recalls / Pharmakon Pharmaceuticals, Inc. / D-1290-2016

D-1290-2016 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
142

Product Description

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80

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-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-1319-2016 Class II — Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 (April 20, 2016)
  • D-1279-2016 Class II — Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHA (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-1310-2016 Class II — Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD (April 20, 2016)
  • D-1257-2016 Class II — Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, 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-1278-2016 Class II — HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Onl (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)