Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chambe...

FDA Recall #D-1160-2014 — Class I — November 18, 2013

Recall #D-1160-2014 Date: November 18, 2013 Classification: Class I Status: Terminated

Product Description

Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.

Reason for Recall

Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Recalling Firm

Baxter Healthcare Corp. — Deerfield, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

7,388 bags

Distribution

US Nationwide

Code Information

Lot# P285122, Exp 5/2014

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated