FDAFDA · Alimentos y medicamentos·N.º oficial D-1368-2016

0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag ; , Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag ; , Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag ; , Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

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 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 ; Service Code 2H8120 , Lot Number 160420181M , Exp. Date 5/12/2016 ; Service Code 2H8120 , Lot Number 160450166M , Exp. Date 5/15/2016 ; Service Code 2H8120 , Lot Number 160460209M , Exp. Date 5/16/2016 ; Service Code 2H8120 , Lot Number 160600277M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610057M , Exp. Date 5/30/2016 ; Service Code 2H8120 , Lot Number 160610224M , Exp. Date 5/31/2016 ; Service Code 2H8120 , Lot Number 160680153M , Exp. Date 6/7/2016 ; Service Code 2H8120 , Lot Number 160810219M , Exp. Date 6/20/2016 ; Service Code 2H8120 , Lot Number 160910124M , Exp. Date 6/29/2016 ; Service Code 2H8120 , Lot Number 160960220M , Exp. Date 7/5/2016 ; Service Code 2H8243 , Lot Number 160530200M , Exp. Date 5/9/2016 ; Service Code 2H8243 , Lot Number 160600047M , Exp. Date 5/16/2016 ; Service Code 2H8243 , Lot Number 160670033M , Exp. Date 5/22/2016 ; Service Code 2H8243 , Lot Number 160810051M , Exp. Date 6/5/2016 ; Service Code 2H8243 , Lot Number 160880267M , Exp. Date 6/13/2016 ; Service Code 2H8243 , Lot Number 160910035M , Exp. Date 6/15/2016 ; Service Code 2H8243 , Lot Number 160950059M , Exp. Date 6/19/2016 ; Service Code 2K8120 , Lot Number 160480190M , Exp. Date 5/18/2016 ; Service Code 2K8120 , Lot Number 160550194M , Exp. Date 5/25/2016 ; Service Code 2K8120 , Lot Number 160940060M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 160410183M , Exp. Date 5/11/2016 ; Service Code 2K8243 , Lot Number 160420152M , Exp. Date 5/12/2016 ; Service Code 2K8243 , Lot Number 160460131M , Exp. Date 5/16/2016 ; Service Code 2K8243 , Lot Number 160490239M , Exp. Date 5/19/2016 ; Service Code 2K8243 , Lot Number 160520184M , Exp. Date 5/22/2016 ; Service Code 2K8243 , Lot Number 160550125M , Exp. Date 5/25/2016 ; Service Code 2K8243 , Lot Number 160590160M , Exp. Date 5/29/2016 ; Service Code 2K8243 , Lot Number 160600171M , Exp. Date 5/30/2016 ; Service Code 2K8243 , Lot Number 160610227M , Exp. Date 5/31/2016 ; Service Code 2K8243 , Lot Number 160620142M , Exp. Date 6/1/2016 ; Service Code 2K8243 , Lot Number 160630199M , Exp. Date 6/2/2016 ; Service Code 2K8243 , Lot Number 160660168M , Exp. Date 6/5/2016 ; Service Code 2K8243 , Lot Number 160670236M , Exp. Date 6/6/2016 ; Service Code 2K8243 , Lot Number 160700192M , Exp. Date 6/9/2016 ; Service Code 2K8243 , Lot Number 160740235M , Exp. Date 6/13/2016 ; Service Code 2K8243 , Lot Number 160760190M , Exp. Date 6/15/2016 ; Service Code 2K8243 , Lot Number 160810280M , Exp. Date 6/20/2016 ; Service Code 2K8243 , Lot Number 160820234M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160830120M , Exp. Date 6/21/2016 ; Service Code 2K8243 , Lot Number 160870168M , Exp. Date 6/26/2016 ; Service Code 2K8243 , Lot Number 160900173M , Exp. Date 6/29/2016 ; Service Code 2K8243 , Lot Number 160910176M , Exp. Date 6/30/2016 ; Service Code 2K8243 , Lot Number 160940041M , Exp. Date 7/2/2016 ; Service Code 2K8243 , Lot Number 161080168M , Exp. Date 7/17/2016 ; Service Code 2K9120 , Lot Number 160380034C , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160380105M , Exp. Date 5/8/2016 ; Service Code 2K9120 , Lot Number 160420030C , Exp. Date 5/12/2016 ; Service Code 2K9120 , Lot Number 160470039C , Exp. Date 5/17/2016 ; Service Code 2K9120 , Lot Number 160540034C , Exp. Date 5/24/2016 ; Service Code 2K9120 , Lot Number 160550029C , Exp. Date 5/25/2016 ; Service Code 2K9120 , Lot Number 160590078M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160600067M , Exp. Date 5/29/2016 ; Service Code 2K9120 , Lot Number 160670187M , Exp. Date 6/6/2016 ; Service Code 2K9120 , Lot Number 160730076M , Exp. Date 6/11/2016 ; Service Code 2K9120 , Lot Number 160750233M , Exp. Date 6/14/2016 ; Service Code 2K9120 , Lot Number 160770001M , Exp. Date 6/15/2016 ; Service Code 2K9120 , Lot Number 160770049M , Exp. Date 6/15/2016 ; Service Code
Clasificación de riesgo: Class II
Área (FDA): drug
País: United States