NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 ...

FDA Recall #D-1020-2017 — Class II — July 14, 2017

Recall #D-1020-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40

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@36 BUD: 7/31/2017; 20170512@1 BUD: 8/10/2017; 20170504@13 BUD: 8/2/2017; 20170504@18 BUD: 8/2/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated