D-0658-2016 Class I Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0658-2016 was initiated by Pharmedium Services, LLC on May 22, 2015 and is designated Class I. Reason for recall: Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. The recall status is terminated (terminated Feb 18, 2016). Affected quantity: 19 Syringes.

Recall Details

Product Type
Drugs
Report Date
Feb 17, 2016
Initiation Date
May 22, 2015
Termination Date
Feb 18, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 Syringes

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.

Distribution Pattern

WI

Code Information

Lot #:151370066M, Exp. 08/15/2015

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0658-2016
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.