FDAFDA · Food and drugs·Recall number D-1392-2016
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), 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 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 ; Service Code 2K9226 , Lot Number 160530166M , Exp. Date 5/17/2016 ; Service Code 2K9226 , Lot Number 160560080M , Exp. Date 5/19/2016 ; Service Code 2K9226 , Lot Number 160670164M , Exp. Date 5/31/2016 ; Service Code 2K9226 , Lot Number 160730130M , Exp. Date 6/6/2016 ; Service Code 2K9226 , Lot Number 160770032M , Exp. Date 6/10/2016 ; Service Code 2K9226 , Lot Number 160810035M , Exp. Date 6/13/2016 ; Service Code 2K9226 , Lot Number 160820135M , Exp. Date 6/15/2016 ; Service Code 2K9226 , Lot Number 160870152M , Exp. Date 6/20/2016 ; Service Code 2K9226 , Lot Number 160890036M , Exp. Date 6/22/2016 ; Service Code 2K9226 , Lot Number 160950040M , Exp. Date 6/27/2016 ; Service Code 2K9294 , Lot Number 160400210M , Exp. Date 5/10/2016 ; Service Code 2K9294 , Lot Number 160700164M , Exp. Date 6/9/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.