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Recall Observatory FDA recall evidence

Drug product

5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48

D-1421-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
2,256 Medical Cassettes
Official record key
drug-enforcement:D-1421-2016

Official wording

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

Code information: Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp. Date 5/7/2016 ; Lot Number 160460328M , Exp. Date 5/7/2016 ; Lot Number 160540052M , Exp. Date 5/15/2016 ; Lot Number 160600338M , Exp. Date 5/21/2016 ; Lot Number 160600339M , Exp. Date 5/21/2016 ; Lot Number 160600340M , Exp. Date 5/21/2016 ; Lot Number 160600341M , Exp. Date 5/21/2016 ; Lot Number 160680065C , Exp. Date 5/29/2016 ; Lot Number 160750039C , Exp. Date 6/5/2016 ; Lot Number 160750040C , Exp. Date 6/5/2016 ; Lot Number 160750041C , Exp. Date 6/5/2016 ; Lot Number 160770040C , Exp. Date 6/7/2016 ; Lot Number 160880030C , Exp. Date 6/18/2016 ; Lot Number 160880031C , Exp. Date 6/18/2016 ; Lot Number 160880032C , Exp. Date 6/17/2016 ; Lot Number 160880033C , Exp. Date 6/18/2016 ; Lot Number 160880034C , Exp. Date 6/18/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter