Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximat...
FDA Recall #D-0979-2017 — Class II — June 21, 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
Recalling Firm
SCA Pharmaceuticals — Little Rock, AR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20 bags
Distribution
LA, PA, NY, WI
Code Information
Lot #: 20170511@58, Exp 6/25/2017
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated