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Recall Observatory FDA recall evidence

Drug product

PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (160 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-169-50

D-1822-2015

January 28, 2015

Class I

Product summary

Firm
Pharmedium Services, LLC
Event
Event 71844
Status
Terminated
Classification
Class I
Quantity
24 bags
Official record key
drug-enforcement:D-1822-2015

Official wording

Reason: Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Code information: Lot #: 14309095S, Exp 02/03/15; 14311008S, Exp 02/05/15

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter