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Recall Observatory FDA recall evidence

Drug product

2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02

D-1401-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
90 bags
Official record key
drug-enforcement:D-1401-2016

Official wording

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

Code information: Lot Number 160420104M , Exp. Date 5/6/2016 ; Lot Number 160450187M , Exp. Date 5/9/2016 ; Lot Number 160530126M , Exp. Date 5/17/2016 ; Lot Number 160680200M , Exp. Date 6/1/2016 ; Lot Number 160730047M , Exp. Date 6/5/2016 ; Lot Number 160750130M , Exp. Date 6/8/2016 ; Lot Number 160830227M , Exp. Date 6/16/2016 ; Lot Number 160870077M , Exp. Date 6/19/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter