FDAFDA · Food and drugs·Recall number D-1395-2016
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 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 3V8701 , Lot Number 160390095M , Exp. Date 5/9/2016 ; Service Code 3V8701 , Lot Number 160480198M , Exp. Date 5/18/2016 ; Service Code 3V8701 , Lot Number 160540108M , Exp. Date 5/24/2016 ; Service Code 3V8701 , Lot Number 160690111M , Exp. Date 6/8/2016 ; Service Code 3V8701 , Lot Number 160740250M , Exp. Date 6/13/2016 ; Service Code 3V8701 , Lot Number 160820104M , Exp. Date 6/21/2016 ; Service Code 3V8701 , Lot Number 160900119M , Exp. Date 6/28/2016 ; Service Code 3V8701 , Lot Number 160970024M , Exp. Date 7/5/2016 ; Service Code 3V8703 , Lot Number 160420127M , Exp. Date 5/6/2016 ; Service Code 3V8703 , Lot Number 160460220M , Exp. Date 5/10/2016 ; Service Code 3V8703 , Lot Number 160530317M , Exp. Date 5/17/2016 ; Service Code 3V8703 , Lot Number 160540155M , Exp. Date 5/18/2016 ; Service Code 3V8703 , Lot Number 160630132M , Exp. Date 5/27/2016 ; Service Code 3V8703 , Lot Number 160660018C , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160660249M , Exp. Date 5/30/2016 ; Service Code 3V8703 , Lot Number 160750261M , Exp. Date 6/8/2016 ; Service Code 3V8703 , Lot Number 160800218M , Exp. Date 6/13/2016 ; Service Code 3V8703 , Lot Number 160910144M , Exp. Date 6/24/2016 ; Service Code 3V8703 , Lot Number 160940249M , Exp. Date 6/27/2016 ; Service Code 3V8703 , Lot Number 161080258M , Exp. Date 7/11/2016 ; Service Code 2C8201 , Lot Number 160960246M , Exp. Date 5/21/2016 ; Service Code 2H8122 , Lot Number 160400260M , Exp. Date 5/6/2016 ; Service Code 2H8122 , Lot Number 160460244M , Exp. Date 5/12/2016 ; Service Code 2H8122 , Lot Number 160530172M , Exp. Date 5/19/2016 ; Service Code 2H8122 , Lot Number 160600231M , Exp. Date 5/26/2016 ; Service Code 2H8122 , Lot Number 160610162M , Exp. Date 5/27/2016 ; Service Code 2H8122 , Lot Number 160660246M , Exp. Date 6/1/2016 ; Service Code 2H8122 , Lot Number 160680217M , Exp. Date 6/3/2016 ; Service Code 2H8122 , Lot Number 160770255M , Exp. Date 6/12/2016 ; Service Code 2H8122 , Lot Number 160800216M , Exp. Date 6/15/2016 ; Service Code 2H8122 , Lot Number 160890198M , Exp. Date 6/24/2016 ; Service Code 2H8122 , Lot Number 160910120M , Exp. Date 6/26/2016 ; Service Code 2H8122 , Lot Number 160940211M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160390320M , Exp. Date 5/9/2016 ; Service Code 2H8131 , Lot Number 160460041M , Exp. Date 5/16/2016 ; Service Code 2H8131 , Lot Number 160480170M , Exp. Date 5/18/2016 ; Service Code 2H8131 , Lot Number 160530268M , Exp. Date 5/23/2016 ; Service Code 2H8131 , Lot Number 160600043M , Exp. Date 5/30/2016 ; Service Code 2H8131 , Lot Number 160660087M , Exp. Date 6/5/2016 ; Service Code 2H8131 , Lot Number 160700178M , Exp. Date 6/9/2016 ; Service Code 2H8131 , Lot Number 160750035M , Exp. Date 6/14/2016 ; Service Code 2H8131 , Lot Number 160810269M , Exp. Date 6/20/2016 ; Service Code 2H8131 , Lot Number 160870108M , Exp. Date 6/26/2016 ; Service Code 2H8131 , Lot Number 160900326M , Exp. Date 6/29/2016 ; Service Code 2H8131 , Lot Number 160960059M , Exp. Date 7/5/2016 ; Service Code 2H8201 , Lot Number 160600054M , Exp. Date 5/16/2016 ; Service Code 2H8201 , Lot Number 160670235M , Exp. Date 5/23/2016 ; Service Code 2H8201 , Lot Number 160740184M , Exp. Date 5/30/2016 ; Service Code 2H8201 , Lot Number 160890267M , Exp. Date 6/14/2016 ; Service Code 2H8201 , Lot Number 160950054M , Exp. Date 6/19/2016 ; Service Code 2H8201 , Lot Number 160960004M , Exp. Date 6/20/2016 ; Service Code 2K8122 , Lot Number 160410134M , Exp. Date 5/7/2016 ; Service Code 2K8122 , Lot Number 160460125M , Exp. Date 5/12/2016 ; Service Code 2K8122 , Lot Number 160520111M , Exp. Date 5/17/2016 ; Service Code 2K8122 , Lot Number 160620030M , Exp. Date 5/27/2016 ; Service Code 2K8122 , Lot Number 160670147M , Exp. Date 6/2/2016 ; Service Code 2K8122 , Lot Number 160740165M , Exp. Date 6/9/2016 ; Service Code 2K8122 , Lot Number 160820129M , Exp. Date 6/17/2016 ; Service Code
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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