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.

FDA recall notice · announced August 27, 2014 · Baxter Healthcare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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).

Notes

Distribution: Nationwide
Lot/code information: Lot #: P306225, Exp 08/14
Quantity: 6,204 bags
Status: Terminated
Products in this recall event:
- 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 (D-1542-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.