FentaNYL Citrate In Sodium Chloride 1600mcg/ CII recalled over sterility concerns

Recall date

January 31, 2025

Source

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

Official notice title

Fagron Compounding Services recalls fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services…

Recall number

D-0225-2025

FDA classification

Class II

Brand / firm

Fagron Compounding Services

Sold / distributed

Distributed in PA

Why it was recalled

Lack of Assurance of Sterility

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 In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01