Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821...

FDA Recall #D-1033-2017 — Class II — July 14, 2017

Recall #D-1033-2017 Date: July 14, 2017 Classification: Class II Status: Terminated

Product Description

Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40

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: 20170509@10 BUD: 7/23/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated