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Recall Observatory FDA recall evidence

Drug product

3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97

D-1413-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
700 bags
Official record key
drug-enforcement:D-1413-2016

Official wording

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

Code information: Lot Number 160420248M , Exp. Date 5/6/2016 ; Lot Number 160490250M , Exp. Date 5/13/2016 ; Lot Number 160600329M , Exp. Date 5/24/2016 ; Lot Number 160620002M , Exp. Date 5/25/2016 ; Lot Number 160660181M , Exp. Date 5/30/2016 ; Lot Number 160760025M , Exp. Date 6/9/2016 ; Lot Number 160870159M , Exp. Date 6/20/2016 ; Lot Number 160940170M , Exp. Date 6/27/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter