FDA recall D-0658-2016

Product

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.

Reason for recall

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

Distribution

WI

Key facts

Status

Terminated

Initiation date

2015-05-22

Report date

2016-02-17

Termination date

2016-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2016