FDAFDA · Food and drugs·Recall number D-1389-2016
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
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
- Lot Number 160390174M , Exp. Date 5/9/2016 ; Lot Number 160400196M , Exp. Date 5/10/2016 ; Lot Number 160470128M , Exp. Date 5/17/2016 ; Lot Number 160530287M , Exp. Date 5/23/2016 ; Lot Number 160540190M , Exp. Date 5/24/2016 ; Lot Number 160590168M , Exp. Date 5/29/2016 ; Lot Number 160610129M , Exp. Date 5/31/2016 ; Lot Number 160680254M , Exp. Date 6/7/2016 ; Lot Number 160700199M , Exp. Date 6/9/2016 ; Lot Number 160750132M , Exp. Date 6/14/2016 ; Lot Number 160770177M , Exp. Date 6/16/2016 ; Lot Number 160810292M , Exp. Date 6/20/2016 ; Lot Number 160820115M , Exp. Date 6/21/2016 ; Lot Number 160840157M , Exp. Date 6/23/2016 ; Lot Number 160880249M , Exp. Date 6/27/2016 ; Lot Number 160890261M , Exp. Date 6/28/2016 ; Lot Number 160940057M , Exp. Date 7/2/2016 ; Lot Number 160960151M , Exp. Date 7/5/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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