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Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium)...

FDA Recall #D-1159-2014 — Class I — November 18, 2013

Recall #D-1159-2014 Date: November 18, 2013 Classification: Class I Status: Terminated

Product Description

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY 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

7,068 bags

Distribution

US Nationwide

Code Information

Lot#: P275883, Exp 10/2013

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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