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Recall Observatory FDA recall evidence

Drug product

HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02.

D-1355-2015

April 13, 2015

Class I

Product summary

Firm
Pharmedium Services, LLC
Event
Event 71846
Status
Terminated
Classification
Class I
Quantity
480 bags
Official record key
drug-enforcement:D-1355-2015

Official wording

Reason: Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Code information: Lot #: 15041123S, 15041003S, Exp 04/16/15

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter