NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, i...
FDA Recall #D-0778-2016 — Class III — December 31, 2015
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
Recalling Firm
Pharmedium Services, LLC — Lake Forest, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Distribution
Nationwide
Code Information
Service Code 2K6127; 15342123S, exp 2/10/2016 15349071S, exp 2/17/2016 and 15351050S, exp 2/19/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated