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Recall Observatory FDA recall evidence

Drug product

Morphine Sulfate, 1 mg per mL (250 mg 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# 61553-181-50

D-1824-2015

January 28, 2015

Class I

Product summary

Firm
Pharmedium Services, LLC
Event
Event 71844
Status
Terminated
Classification
Class I
Quantity
100 bags
Official record key
drug-enforcement:D-1824-2015

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 #: 14308162M, Exp 02/02/15; 143130049M, Exp 02/08/15; 143220039M, Exp 02/16/15; 143490058M, Exp 03/16/15; 143560029M, Exp 03/23/15

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter