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D-1542-2014 Class II Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA drug recall D-1542-2014 was initiated by Baxter Healthcare Corp on Aug 4, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jun 10, 2015). Affected quantity: 6,204 bags.

Recall Details

Product Type: Drugs
Report Date: Aug 27, 2014
Initiation Date: Aug 4, 2014
Termination Date: Jun 10, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,204 bags

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).

Distribution Pattern

Nationwide

Code Information

Lot #: P306225, Exp 08/14

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1542-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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