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Recall Observatory FDA recall evidence

Drug product

5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.

D-1162-2014

November 21, 2013

Class I

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 67092
Status
Terminated
Classification
Class I
Quantity
105,216 containers
Official record key
drug-enforcement:D-1162-2014

Official wording

Reason: Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Code information: Lot #: P285288, Exp 11/13

Distribution pattern: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter