PlainRecalls
FDA Drug Moderate Class II Terminated

Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40

Reported: July 19, 2017 Initiated: June 21, 2017 #D-0979-2017

Product Description

Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40

Reason for Recall

Lack of sterility assurance

Details

Recalling Firm
SCA Pharmaceuticals
Units Affected
20 bags
Distribution
LA, PA, NY, WI
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40. Recalled by SCA Pharmaceuticals. Units affected: 20 bags.
Why was this product recalled?
Lack of sterility assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on July 19, 2017. Severity: Moderate. Recall number: D-0979-2017.