NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, i...
FDA Recall #D-0777-2016 — Class III — December 31, 2015
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
Recalling Firm
Pharmedium Services, LLC — Lake Forest, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
6,816 bags
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated