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Recall Observatory FDA recall evidence

Drug product

10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,

D-1386-2016

May 05, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74057
Status
Terminated
Classification
Class II
Quantity
1,234 Medical Cassettes
Official record key
drug-enforcement:D-1386-2016

Official wording

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

Code information: Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 ; Service Code 2H8481 , Lot Number 160540181M , Exp. Date 5/24/2016 ; Service Code 2H8481 , Lot Number 160830170M , Exp. Date 6/22/2016 ; Service Code 2K8481 , Lot Number 160380110M , Exp. Date 5/8/2016 ; Service Code 2K8481 , Lot Number 160390206M , Exp. Date 5/9/2016 ; Service Code 2K8481 , Lot Number 160400241M , Exp. Date 5/10/2016 ; Service Code 2K8481 , Lot Number 160410170M , Exp. Date 5/11/2016 ; Service Code 2K8481 , Lot Number 160450130M , Exp. Date 5/15/2016 ; Service Code 2K8481 , Lot Number 160480181M , Exp. Date 5/18/2016 ; Service Code 2K8481 , Lot Number 160520033M , Exp. Date 5/22/2016 ; Service Code 2K8481 , Lot Number 160530127M , Exp. Date 5/23/2016 ; Service Code 2K8481 , Lot Number 160540137M , Exp. Date 5/24/2016 ; Service Code 2K8481 , Lot Number 160560212M , Exp. Date 5/26/2016 ; Service Code 2K8481 , Lot Number 160600294M , Exp. Date 5/30/2016 ; Service Code 2K8481 , Lot Number 160610237M , Exp. Date 5/31/2016 ; Service Code 2K8481 , Lot Number 160630118M , Exp. Date 6/2/2016 ; Service Code 2K8481 , Lot Number 160660175M , Exp. Date 6/5/2016 ; Service Code 2K8481 , Lot Number 160670245M , Exp. Date 6/6/2016 ; Service Code 2K8481 , Lot Number 160730063M , Exp. Date 6/12/2016 ; Service Code 2K8481 , Lot Number 160770227M , Exp. Date 6/16/2016 ; Service Code 2K8481 , Lot Number 160840171M , Exp. Date 6/23/2016 ; Service Code 2K8481 , Lot Number 160870146M , Exp. Date 6/26/2016 ; Service Code 2K8481 , Lot Number 160910219M , Exp. Date 6/30/2016 ; Service Code 2K8481 , Lot Number 160940163M , Exp. Date 7/3/2016 ; Service Code 2K8481 , Lot Number 160970137M , Exp. Date 7/6/2016 ; Service Code 2K8481 , Lot Number 161080124M , Exp. Date 7/17/2016 ; Service Code 2K8909 , Lot Number 160910236M , Exp. Date 5/7/2016 ; Service Code 2K8909 , Lot Number 160950070C , Exp. Date 5/11/2016 ; Service Code 2K8909 , Lot Number 161080282M , Exp. Date 5/24/2016 ; Service Code 2K8911 , Lot Number 160970035M , Exp. Date 5/6/2016 ; Service Code 2T6481 , Lot Number 160590144M , Exp. Date 5/29/2016 ; Service Code 2T6481 , Lot Number 160610031M , Exp. Date 5/31/2016 ;

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter