Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium)...
FDA Recall #D-0301-2015 — Class II — November 25, 2014
Product Description
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Reason for Recall
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Recalling Firm
Baxter Healthcare Corp. — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,220 bags
Distribution
Nationwide
Code Information
Product Code 2B7717 Lot # P311357, exp 12/31/2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated