PlainRecalls
FDA Drug Moderate Class II Terminated

Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Reported: February 3, 2016 Initiated: August 19, 2015 #D-0596-2016

Product Description

Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Reason for Recall

Stability data does not support expiry.

Details

Recalling Firm
Pharmakon Pharmaceuticals
Units Affected
7100
Distribution
Nationwide
Location
Noblesville, IN

Frequently Asked Questions

What product was recalled?
Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.. Recalled by Pharmakon Pharmaceuticals. Units affected: 7100.
Why was this product recalled?
Stability data does not support expiry.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 3, 2016. Severity: Moderate. Recall number: D-0596-2016.