FDA recall D-1033-2017

SCA Pharmaceuticals · Class II · drug

Product

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-07-14
Report date: 2017-08-02
Termination date: 2019-05-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1033-2017