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Recall Observatory FDA recall evidence

Drug product

Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in a 250 mL LifeCare bag in Sodium Chloride 0.9%, IV Use Only, Rx only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-107-50

D-1825-2015

January 28, 2015

Class I

Product summary

Firm
Pharmedium Services, LLC
Event
Event 71844
Status
Terminated
Classification
Class I
Quantity
663 bags
Official record key
drug-enforcement:D-1825-2015

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 #: 14303122M, Exp 01/28/15; 14309029M, Exp 02/02/15; 14315067M, Exp 02/09/15; 14317040M, Exp 02/11/15; 14318026M, Exp 02/12/15; 14323089M, Exp 02/17/15; 14325128M, 14325124M, Exp 02/19/15

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter