Pharmakon Pharmaceuticals recalls Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2…

Recall date

August 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0596-2016

FDA classification

Class II

Brand / firm

Pharmakon Pharmaceuticals

Sold / distributed

Nationwide

Why it was recalled

Stability data does not support expiry.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.