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Recall Observatory FDA recall evidence

Drug product

1 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9232, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-032-95

D-1374-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
361 bags
Official record key
drug-enforcement:D-1374-2016

Official wording

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

Code information: Lot Number 160460204M , Exp. Date 5/10/2016 ; Lot Number 160560170M , Exp. Date 5/20/2016 ; Lot Number 160700007M , Exp. Date 6/2/2016 ; Lot Number 160810176M , Exp. Date 6/14/2016 ; Lot Number 160830325M , Exp. Date 6/16/2016 ; Lot Number 160880270M , Exp. Date 6/21/2016 ; Lot Number 160890245M , Exp. Date 6/22/2016 ; Lot Number 160900144M , Exp. Date 6/23/2016 ; Lot Number 160950241M , Exp. Date 6/28/2016 ; Lot Number 161080135M , Exp. Date 7/11/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter