FDAFDA · Food and drugs·Recall number D-1396-2016

2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Published July 27, 2016 · Recall initiated: May 5, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer: Pharmedium Services, LLC
Distributor: Nationwide
Lot: Service Code 3V8705 , Lot Number 160380161M , Exp. Date 5/8/2016 ; Service Code 3V8705 , Lot Number 160400200M , Exp. Date 5/10/2016 ; Service Code 3V8705 , Lot Number 160460205M , Exp. Date 5/15/2016 ; Service Code 3V8705 , Lot Number 160530278M , Exp. Date 5/23/2016 ; Service Code 3V8705 , Lot Number 160610204M , Exp. Date 5/31/2016 ; Service Code 3V8705 , Lot Number 160630155M , Exp. Date 6/2/2016 ; Service Code 3V8705 , Lot Number 160700159M , Exp. Date 6/9/2016 ; Service Code 3V8705 , Lot Number 160770234M , Exp. Date 6/16/2016 ; Service Code 3V8705 , Lot Number 160800199M , Exp. Date 6/19/2016 ; Service Code 3V8705 , Lot Number 160840217M , Exp. Date 6/23/2016 ; Service Code 3V8705 , Lot Number 161080171M , Exp. Date 7/17/2016 ; Service Code 3V8707 , Lot Number 160460233M , Exp. Date 5/10/2016 ; Service Code 3V8707 , Lot Number 160530170M , Exp. Date 5/17/2016 ; Service Code 3V8707 , Lot Number 160660139M , Exp. Date 5/30/2016 ; Service Code 3V8707 , Lot Number 160670160M , Exp. Date 5/31/2016 ; Service Code 3V8707 , Lot Number 160730245M , Exp. Date 6/6/2016 ; Service Code 3V8707 , Lot Number 160810188M , Exp. Date 6/14/2016 ; Service Code 3V8707 , Lot Number 160880197M , Exp. Date 6/21/2016 ; Service Code 3V8707 , Lot Number 160940223M , Exp. Date 6/27/2016 ; Service Code 3V8707 , Lot Number 160960010M , Exp. Date 6/28/2016 ; Service Code 2C8124 , Lot Number 160870072M , Exp. Date 5/11/2016 ; Service Code 2C8124 , Lot Number 160960047M , Exp. Date 5/20/2016 ; Service Code 2C8205 , Lot Number 160810170M , Exp. Date 5/6/2016 ; Service Code 2C8205 , Lot Number 160890184M , Exp. Date 5/14/2016 ; Service Code 2C8205 , Lot Number 160910167M , Exp. Date 5/15/2016 ; Service Code 2C8205 , Lot Number 160970129M , Exp. Date 5/21/2016 ; Service Code 2H8125 , Lot Number 160420030M , Exp. Date 5/8/2016 ; Service Code 2H8125 , Lot Number 160450359M , Exp. Date 5/11/2016 ; Service Code 2H8125 , Lot Number 160460339M , Exp. Date 5/12/2016 ; Service Code 2H8125 , Lot Number 160490036M , Exp. Date 5/15/2016 ; Service Code 2H8125 , Lot Number 160550173M , Exp. Date 5/21/2016 ; Service Code 2H8125 , Lot Number 160590318M , Exp. Date 5/25/2016 ; Service Code 2H8125 , Lot Number 160620310M , Exp. Date 5/28/2016 ; Service Code 2H8125 , Lot Number 160670054M , Exp. Date 6/2/2016 ; Service Code 2H8125 , Lot Number 160700048M , Exp. Date 6/5/2016 ; Service Code 2H8125 , Lot Number 160770057M , Exp. Date 6/12/2016 ; Service Code 2H8125 , Lot Number 160820240M , Exp. Date 6/17/2016 ; Service Code 2H8125 , Lot Number 160830048M , Exp. Date 6/18/2016 ; Service Code 2H8125 , Lot Number 160880059M , Exp. Date 6/23/2016 ; Service Code 2H8125 , Lot Number 160910192M , Exp. Date 6/26/2016 ; Service Code 2H8125 , Lot Number 160960058M , Exp. Date 7/1/2016 ; Service Code 2H8204 , Lot Number 160600191M , Exp. Date 5/16/2016 ; Service Code 2H8204 , Lot Number 160680245M , Exp. Date 5/24/2016 ; Service Code 2H8204 , Lot Number 160700134M , Exp. Date 5/25/2016 ; Service Code 2H8204 , Lot Number 160740161M , Exp. Date 5/30/2016 ; Service Code 2H8204 , Lot Number 160750188M , Exp. Date 5/31/2016 ; Service Code 2H8204 , Lot Number 160810201M , Exp. Date 6/6/2016 ; Service Code 2H8204 , Lot Number 160910156M , Exp. Date 6/16/2016 ; Service Code 2H8204 , Lot Number 161080147M , Exp. Date 7/3/2016 ; Service Code 2H8205 , Lot Number 160460042M , Exp. Date 5/16/2016 ; Service Code 2H8205 , Lot Number 160530269M , Exp. Date 5/23/2016 ; Service Code 2H8205 , Lot Number 160600058M , Exp. Date 5/30/2016 ; Service Code 2H8205 , Lot Number 160670225M , Exp. Date 6/6/2016 ; Service Code 2H8205 , Lot Number 160700039M , Exp. Date 6/9/2016 ; Service Code 2H8205 , Lot Number 160750027M , Exp. Date 6/14/2016 ; Service Code 2H8205 , Lot Number 160810038M , Exp. Date 6/20/2016 ; Service Code 2H8205 , Lot Number 160870101M , Exp. Date 6/26/2016 ; Service Code 2H8205 , Lot Number 160890057M , Exp. Date 6/28/2016 ; Service Cod
Risk classification: Class II
Area (FDA): drug
Country: United States

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