Pharmedium Services, LLC recalls remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a s…

Recall date

July 17, 2015

Source

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

Recall number

D-0088-2017

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

remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.