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Recall Observatory FDA recall evidence

Drug product

10 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8142, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-142-02

D-1380-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1380-2016

Official wording

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

Code information: Lot Number 160460189M , Exp. Date 5/10/2016 ; Lot Number 160480179M , Exp. Date 5/12/2016 ; Lot Number 160520105M , Exp. Date 5/15/2016 ; Lot Number 160530291M , Exp. Date 5/17/2016 ; Lot Number 160540130M , Exp. Date 5/17/2016 ; Lot Number 160550186M , Exp. Date 5/19/2016 ; Lot Number 160560087M , Exp. Date 5/19/2016 ; Lot Number 160590074M , Exp. Date 5/23/2016 ; Lot Number 160620037M , Exp. Date 5/25/2016 ; Lot Number 160630028M , Exp. Date 5/26/2016 ; Lot Number 160660039M , Exp. Date 5/29/2016 ; Lot Number 160730059M , Exp. Date 6/6/2016 ; Lot Number 160740234M , Exp. Date 6/7/2016 ; Lot Number 160800073M , Exp. Date 6/12/2016 ; Lot Number 160820049M , Exp. Date 6/14/2016 ; Lot Number 160890045M , Exp. Date 6/21/2016 ; Lot Number 160970197M , Exp. Date 6/30/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter