PharMEDium Services, LLC recalls HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel S…

Recall date

March 16, 2020

Source

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

Recall number

D-1084-2020

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

HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44