PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl ...
FDA Recall #D-1026-2017 — Class II — July 14, 2017
Product Description
PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59
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: 20170503@29 BUD: 8/1/2017; 20170512@22 BUD: 8/10/2017; 20170509@64 BUD: 8/7/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated