FDA-Drug2014-08-27Class II

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.

Baxter Healthcare Corp
Hazard

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).

Sold states
Nationwide
Affected count
6,204 bags
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1542-2014

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