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Recall Observatory FDA recall evidence

Drug product

2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50

D-1403-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
105 bags
Official record key
drug-enforcement:D-1403-2016

Official wording

Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Code information: Lot Number 160890247M , Exp. Date 6/28/2016 ; Lot Number 160380151M , Exp. Date 5/8/2016 ; Lot Number 160490238M , Exp. Date 5/19/2016 ; Lot Number 160550208M , Exp. Date 5/25/2016 ; Lot Number 160610062M , Exp. Date 5/30/2016 ; Lot Number 160630184M , Exp. Date 6/2/2016 ; Lot Number 160700191M , Exp. Date 6/9/2016 ; Lot Number 160750045M , Exp. Date 6/13/2016 ; Lot Number 160770156M , Exp. Date 6/16/2016 ; Lot Number 160910163M , Exp. Date 6/30/2016 ; Lot Number 160810279M , Exp. Date 6/20/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter