FDAClass IIAugust 27, 2014

ProSol - sulfite-free recall: Particulate Matter

ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division…

Why was ProSol - sulfite-free recalled?

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: P306225, Exp 08/14

Product
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division…
Recalling firm
Baxter Healthcare Corp
Quantity
6,204 bags
Distribution
Nationwide
Recall date
August 27, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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