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Recall Observatory FDA recall evidence

Drug product

6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86

D-1433-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
79 syringes
Official record key
drug-enforcement:D-1433-2016

Official wording

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

Code information: Lot Number 160450146M , Exp. Date 5/14/2016 ; Lot Number 160520168M , Exp. Date 5/22/2016 ; Lot Number 160620181M , Exp. Date 6/1/2016 ; Lot Number 160760038M , Exp. Date 6/14/2016 ; Lot Number 160900172M , 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