Pharmedium Services, LLC recalls Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chlori…

Recall date

May 22, 2015

Source

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

Recall number

D-0658-2016

FDA classification

Class I

Brand / firm

Pharmedium Services, LLC

Sold / distributed

WI

Why it was recalled

Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.