PlainRecalls
FDA Drug Moderate Class II Terminated

Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03

Reported: July 20, 2016 Initiated: April 20, 2016 #D-1295-2016

Product Description

Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
384
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Location
Noblesville, IN

Frequently Asked Questions

What product was recalled?
Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03. Recalled by Pharmakon Pharmaceuticals, Inc.. Units affected: 384.
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-1295-2016.