PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: February 17, 2016 Initiated: May 22, 2015 #D-0658-2016

Product Description

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.

Details

Recalling Firm
Pharmedium Services, LLC
Units Affected
19 Syringes
Distribution
WI
Location
Lake Forest, IL

Frequently Asked Questions

What product 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.. Recalled by Pharmedium Services, LLC. Units affected: 19 Syringes.
Why was this product recalled?
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 17, 2016. Severity: Critical. Recall number: D-0658-2016.