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Recall Observatory FDA recall evidence

Drug product

10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52

D-1379-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
750 bags
Official record key
drug-enforcement:D-1379-2016

Official wording

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

Code information: Lot Number 160460017C , Exp. Date 5/12/2016 ; Lot Number 160600019C , Exp. Date 5/26/2016 ; Lot Number 160670016C , Exp. Date 6/2/2016 ; Lot Number 160740027C , Exp. Date 6/9/2016 ; Lot Number 160810024C , Exp. Date 6/16/2016 ; Lot Number 160880005C , Exp. Date 6/23/2016 ; Lot Number 160950036M , Exp. Date 6/29/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter