PharMEDium Services, LLC recalls fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in…

Recall date

March 16, 2020

Source

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

Recall number

D-1089-2020

FDA classification

Class II

Brand / firm

PharMEDium Services, LLC

Sold / distributed

Distributed Nationwide in the US

Why it was recalled

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

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 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44