Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate...
FDA Recall #D-0976-2017 — Class II — June 21, 2017
Product Description
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
Reason for Recall
Lack of sterility assurance
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
221 bags
Distribution
LA, PA, NY, WI
Code Information
Lot #: 20170509@2, Exp 6/23/2017; 20170524@22, Exp 7/8/2017; 20170602@10, Exp 7/17/2017; 20170609@27, Exp 7/24/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated