PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 20, 2016 Initiated: April 20, 2016 #D-1306-2016

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

Details

Units Affected
50
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Location
Noblesville, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by Pharmakon Pharmaceuticals, Inc.. Units affected: 50.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on July 20, 2016. Severity: Moderate. Recall number: D-1306-2016.