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Recall Observatory FDA recall evidence

Drug product

8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9310, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-310-50

D-1434-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
650 bags
Official record key
drug-enforcement:D-1434-2016

Official wording

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

Code information: Lot Number 160390094M , Exp. Date 5/9/2016 ; Lot Number 160450111M , Exp. Date 5/15/2016 ; Lot Number 160520101M , Exp. Date 5/22/2016 ; Lot Number 160550109M , Exp. Date 5/25/2016 ; Lot Number 160610124M , Exp. Date 5/31/2016 ; Lot Number 160620115M , Exp. Date 6/1/2016 ; Lot Number 160670036M , Exp. Date 6/5/2016 ; Lot Number 160680038M , Exp. Date 6/7/2016 ; Lot Number 160690110M , Exp. Date 6/7/2016 ; Lot Number 160740117M , Exp. Date 6/12/2016 ; Lot Number 160760109M , Exp. Date 6/15/2016 ; Lot Number 160820103M , Exp. Date 6/21/2016 ; Lot Number 160830107M , Exp. Date 6/22/2016 ; Lot Number 160900032M , Exp. Date 6/29/2016 ; Lot Number 160970021M , Exp. Date 7/6/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter