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Recall Observatory FDA recall evidence

Drug 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.

D-1542-2014

August 04, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp
Event
Event 68963
Status
Terminated
Classification
Class II
Quantity
6,204 bags
Official record key
drug-enforcement:D-1542-2014

Official wording

Reason: 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).

Code information: Lot #: P306225, Exp 08/14

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter