PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl ...

FDA Recall #D-1030-2017 — Class II — July 14, 2017

Recall #D-1030-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40

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

Lot: 20170503@19 BUD: 8/1/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated