PlainRecalls
FDA Drug Moderate Class II Terminated

ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.

Reported: August 27, 2014 Initiated: August 4, 2014 #D-1542-2014

Product Description

ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.

Reason for Recall

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).

Details

Recalling Firm
Baxter Healthcare Corp
Units Affected
6,204 bags
Distribution
Nationwide
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06.. Recalled by Baxter Healthcare Corp. Units affected: 6,204 bags.
Why was this product 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).
Which agency issued this recall?
This recall was issued by the FDA Drug on August 27, 2014. Severity: Moderate. Recall number: D-1542-2014.