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Recall Observatory FDA recall evidence

Drug product

2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02

D-1407-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
380 bags
Official record key
drug-enforcement:D-1407-2016

Official wording

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

Code information: Lot Number 160530277M , Exp. Date 5/17/2016 ; Lot Number 160610199M , Exp. Date 5/25/2016 ; Lot Number 160660176M , Exp. Date 5/30/2016 ; Lot Number 160690200M , Exp. Date 6/2/2016 ; Lot Number 160770187M , Exp. Date 6/10/2016 ; Lot Number 160890268M , Exp. Date 6/22/2016 ; Lot Number 160960227M , 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