NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 ...
FDA Recall #D-1021-2017 — Class II — July 14, 2017
Product Description
NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40
Reason for Recall
Lack of Assurance of Sterility; product has the potential to leak.
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide
Code Information
Lots: 20170502@31 BUD: 7/16/2017; 20170508@34 BUD: 7/22/2017; 20170508@70 BUD: 7/22/2017; 20170512@15 BUD: 7/26/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated