Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual C...

FDA Recall #D-1158-2014 — Class I — November 18, 2013

Recall #D-1158-2014 Date: November 18, 2013 Classification: Class I Status: Terminated

Product Description

Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.

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

14,574 bags

Distribution

US Nationwide

Code Information

Lot#: P287045, Exp 6/2014

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated