Pharmedium Services, LLC recalls Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fen…

Recall date

July 17, 2015

Source

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

Recall number

D-0032-2017

FDA classification

Class II

Brand / firm

Pharmedium Services, LLC

Sold / distributed

Nationwide

Why it was recalled

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

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 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.