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Recall Observatory FDA recall evidence

Drug product

2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

D-1394-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
1,280 Medical Cassettes
Official record key
drug-enforcement:D-1394-2016

Official wording

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

Code information: Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp. Date 5/12/2016 ; Service Code 2K8176 , Lot Number 160560160M , Exp. Date 5/20/2016 ; Service Code 2K8176 , Lot Number 160630171M , Exp. Date 5/27/2016 ; Service Code 2K8176 , Lot Number 160690141M , Exp. Date 6/2/2016 ; Service Code 2K8176 , Lot Number 160740128M , Exp. Date 6/7/2016 ; Service Code 2K8176 , Lot Number 160750247M , Exp. Date 6/8/2016 ; Service Code 2K8176 , Lot Number 160810137M , Exp. Date 6/14/2016 ; Service Code 2K8176 , Lot Number 160870187M , Exp. Date 6/20/2016 ; Service Code 2K8176 , Lot Number 160940253M , Exp. Date 6/27/2016 ; Service Code 2K8176 , Lot Number 161080131M , Exp. Date 7/11/2016 ; Service Code 2K8871 , Lot Number 160480223M , Exp. Date 5/8/2016 ; Service Code 2K8871 , Lot Number 160670054C , Exp. Date 5/28/2016 ; Service Code 2K8871 , Lot Number 160870033C , Exp. Date 6/17/2016 ; Service Code 2K8967 , Lot Number 16092001C , Exp. Date 6/21/2016 ; Service Code 2T8871 , Lot Number 160970026M , Exp. Date 5/7/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter