D-0778-2016 Class III Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0778-2016 was initiated by Pharmedium Services, LLC on Dec 31, 2015 and is designated Class III. Reason for recall: Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration The recall status is terminated (terminated Apr 6, 2016).

Recall Details

Product Type
Drugs
Report Date
Mar 23, 2016
Initiation Date
Dec 31, 2015
Termination Date
Apr 6, 2016
Voluntary/Mandated
Voluntary: Firm initiated

Product Description

NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag Black, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-127-61

Reason for Recall

Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Distribution Pattern

Nationwide

Code Information

Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0778-2016
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.