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Recall Observatory FDA recall evidence

Drug product

2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,

D-1402-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
95 bags
Official record key
drug-enforcement:D-1402-2016

Official wording

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

Code information: Service Code 2H8103 , Lot Number 160450153M , Exp. Date 5/11/2016 ; Service Code 2K8444 , Lot Number 160490047C , Exp. Date 5/13/2016 ; Service Code 2K8444 , Lot Number 160540031C , Exp. Date 5/18/2016 ; Service Code 2K8444 , Lot Number 160610039C , Exp. Date 5/25/2016 ; Service Code 2K8444 , Lot Number 160730032C , Exp. Date 6/6/2016 ; Service Code 2K8444 , Lot Number 160760038C , Exp. Date 6/9/2016 ; Service Code 2K8444 , Lot Number 160800049C , Exp. Date 6/13/2016 ; Service Code 2K8444 , Lot Number 160960053C , 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