PharMedium Services, Llc recalls Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag…

Recall date

April 6, 2017

Source

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

Recall number

D-1165-2017

FDA classification

Class II

Brand / firm

PharMedium Services, Llc

Sold / distributed

Nationwide

Why it was recalled

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

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 (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.