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FDAFDA · Alimentos y medicamentos·N.º oficial D-1391-2016

2 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9966, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-966-95

Publicado el 27 de julio de 2016 · Inicio del retiro: 5 de mayo de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · E-Mail

Detalles del retiro

Fabricante
Pharmedium Services, LLC
Distribuidor
Nationwide
Lote
Service Code 2K9966 , Lot Number 160390021M , Exp. Date 5/9/2016 ; Service Code 2K9966 , Lot Number 160450151M , Exp. Date 5/15/2016 ; Service Code 2K9966 , Lot Number 160610223M , Exp. Date 5/31/2016 ; Service Code 2K9966 , Lot Number 160660080M , Exp. Date 6/5/2016 ; Service Code 2K9966 , Lot Number 160880210M , Exp. Date 6/27/2016 ; Service Code 2K9966 , Lot Number 160890277M , Exp. Date 6/28/2016 ; Service Code 2K9966 , Lot Number 160910004M , Exp. Date 6/29/2016 ; Service Code 3V8709 , Lot Number 160550119M , Exp. Date 5/19/2016 ; Service Code 3V8709 , Lot Number 160630116M , Exp. Date 5/27/2016 ; Service Code 3V8709 , Lot Number 160750050M , Exp. Date 6/7/2016 ; Service Code 3V8709 , Lot Number 160890054M , Exp. Date 6/21/2016 ; Service Code 3V8724 , Lot Number 160390325M , Exp. Date 5/9/2016 ; Service Code 3V8724 , Lot Number 160600304M , Exp. Date 5/30/2016 ; Service Code 3V8724 , Lot Number 160770031M , Exp. Date 6/15/2016 ; Service Code 3V8724 , Lot Number 160880271M , Exp. Date 6/27/2016 ; Service Code 2H8129 , Lot Number 160540238M , Exp. Date 5/20/2016 ; Service Code 2H8129 , Lot Number 160590104M , Exp. Date 5/25/2016 ; Service Code 2H8129 , Lot Number 160660247M , Exp. Date 6/1/2016 ; Service Code 2H8129 , Lot Number 160730274M , Exp. Date 6/8/2016 ; Service Code 2H8129 , Lot Number 160810226M , Exp. Date 6/16/2016 ; Service Code 2H8129 , Lot Number 160840032M , Exp. Date 6/19/2016 ; Service Code 2H8129 , Lot Number 160940173M , Exp. Date 6/29/2016 ; Service Code 2H8129 , Lot Number 161080115M , Exp. Date 7/13/2016 ; Service Code 2H8132 , Lot Number 160390248M , Exp. Date 5/9/2016 ; Service Code 2H8132 , Lot Number 160460217M , Exp. Date 5/16/2016 ; Service Code 2H8132 , Lot Number 160490227M , Exp. Date 5/19/2016 ; Service Code 2H8132 , Lot Number 160530175M , Exp. Date 5/23/2016 ; Service Code 2H8132 , Lot Number 160600229M , Exp. Date 5/30/2016 ; Service Code 2H8132 , Lot Number 160660244M , Exp. Date 6/5/2016 ; Service Code 2H8132 , Lot Number 160700169M , Exp. Date 6/9/2016 ; Service Code 2H8132 , Lot Number 160750149M , Exp. Date 6/14/2016 ; Service Code 2H8132 , Lot Number 160830147M , Exp. Date 6/22/2016 ; Service Code 2H8132 , Lot Number 160890269M , Exp. Date 6/28/2016 ; Service Code 2H8132 , Lot Number 160940240M , Exp. Date 7/3/2016 ; Service Code 2K8121 , Lot Number 160380131M , Exp. Date 5/8/2016 ; Service Code 2K8121 , Lot Number 160410135M , Exp. Date 5/11/2016 ; Service Code 2K8121 , Lot Number 160490155M , Exp. Date 5/19/2016 ; Service Code 2K8121 , Lot Number 160550154M , Exp. Date 5/25/2016 ; Service Code 2K8121 , Lot Number 160600215M , Exp. Date 5/30/2016 ; Service Code 2K8121 , Lot Number 160660234M , Exp. Date 6/5/2016 ; Service Code 2K8121 , Lot Number 160730257M , Exp. Date 6/12/2016 ; Service Code 2K8121 , Lot Number 160800137M , Exp. Date 6/19/2016 ; Service Code 2K8121 , Lot Number 160830143M , Exp. Date 6/22/2016 ; Service Code 2K8121 , Lot Number 160910135M , Exp. Date 6/30/2016 ; Service Code 2K8121 , Lot Number 160940233M , Exp. Date 7/3/2016 ; Service Code 2K8132 , Lot Number 160420102M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420214M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160420342M , Exp. Date 5/6/2016 ; Service Code 2K8132 , Lot Number 160450074M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450075M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160450364M , Exp. Date 5/9/2016 ; Service Code 2K8132 , Lot Number 160470314M , Exp. Date 5/11/2016 ; Service Code 2K8132 , Lot Number 160480039M , Exp. Date 5/12/2016 ; Service Code 2K8132 , Lot Number 160520295M , Exp. Date 5/16/2016 ; Service Code 2K8132 , Lot Number 160530061M , Exp. Date 5/17/2016 ; Service Code 2K8132 , Lot Number 160550332M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160550333M , Exp. Date 5/19/2016 ; Service Code 2K8132 , Lot Number 160590128M , Exp. Date 5/23/2016 ; Service Code 2K81
Clasificación de riesgo
Class II
Área (FDA)
drug
País
United States

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