Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Vo...
FDA Recall #D-0977-2017 — Class II — June 21, 2017
Product Description
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
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
660 bags
Distribution
LA, PA, NY, WI
Code Information
Lot #: 20170509@6, Exp 6/23/2017; 20170519@35, Exp 7/3/2017; 20170523@22, Exp 7/7/2017; 20170525@9, Exp 7/9/2017; 20170605@49, Exp 7/20/2017; 20170605@9, Exp 7/20/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated