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Recall Observatory FDA recall evidence

Drug product

10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50

D-1378-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
65 bags
Official record key
drug-enforcement:D-1378-2016

Official wording

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

Code information: Service Code 2H8143 , Lot Number 160830115M , Exp. Date 6/22/2016 ; Service Code 2H8143 , Lot Number 160910155M , Exp. Date 6/30/2016 ; Service Code 2K8448 , Lot Number 160480205M , Exp. Date 5/12/2016 ; Service Code 2K8448 , Lot Number 160610064M , Exp. Date 5/24/2016 ; Service Code 2K8448 , Lot Number 160760042M , Exp. Date 6/9/2016 ; Service Code 2K8448 , Lot Number 160890047M , Exp. Date 6/22/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter