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Recall Observatory FDA recall evidence

Drug product

3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30

D-1417-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
1,015 bags
Official record key
drug-enforcement:D-1417-2016

Official wording

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

Code information: Lot Number 160390336M , Exp. Date 5/9/2016 ; Lot Number 160530318M , Exp. Date 5/23/2016 ; Lot Number 160600347M , Exp. Date 5/30/2016 ; Lot Number 160750243M , Exp. Date 6/14/2016 ; Lot Number 160760164M , Exp. Date 6/14/2016 ; Lot Number 160830228M , Exp. Date 6/22/2016 ; Lot Number 160890224M , Exp. Date 6/28/2016 ; Lot Number 160960242M , Exp. Date 7/5/2016 ; Lot Number 160970140M , 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