PlainRecalls
FDA Drug Moderate Class II Terminated

Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02

Reported: July 20, 2016 Initiated: April 20, 2016 #D-1277-2016

Product Description

Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
10
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA
Location
Noblesville, IN

Frequently Asked Questions

What product was recalled?
Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02. Recalled by Pharmakon Pharmaceuticals, Inc.. Units affected: 10.
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-1277-2016.