Drug recall D-1542-2014

Class II Terminated reported Aug 27, 2014

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).

Lots and codes

Lot #: P306225, Exp 08/14

Recall details

Recalling firm
Baxter Healthcare Corp, Deerfield, IL
Quantity
6,204 bags
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 4, 2014
Terminated
June 10, 2015

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