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D-0777-2016 Class III Terminated

Recalled by Pharmedium Services, LLC — Lake Forest, IL

FDA drug recall D-0777-2016 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). Affected quantity: 6,816 bags.

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 Quantity: 6,816 bags

Product Description

NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Service Code 2K6134; 15342084S, 15342191S, 15342223S, 15342224S, 15342225S, and 15342226S, exp 2/10/2016; 15343025S, 15343026S, 15343129S, and 15343131S, exp 2/11/2016; 15344157S, 15344160S, and 15344209S, exp 2/12/2016; 15345036S, 15345104S, 15345106S, and 15345142S, exp 2/13/2016; 15346015S, 15346016S, 15346017S, 15346018S, 15346019S, 15346020S, 15346022S, and 15346023S, exp 2/14/2016; 15348152S, and 15348197S, exp 2/16/2016 15350046S, and 15350154S, exp 2/18/2016

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0777-2016
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.

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