FDAFDA · Food and drugs·Recall number D-1429-2016
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), 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 2H8477 , Lot Number 160400137M , Exp. Date 5/10/2016 ; Service Code 2H8477 , Lot Number 160450131M , Exp. Date 5/15/2016 ; Service Code 2H8477 , Lot Number 160470138M , Exp. Date 5/17/2016 ; Service Code 2H8477 , Lot Number 160480132M , Exp. Date 5/18/2016 ; Service Code 2H8477 , Lot Number 160550129M , Exp. Date 5/25/2016 ; Service Code 2H8477 , Lot Number 160610059M , Exp. Date 5/30/2016 ; Service Code 2H8477 , Lot Number 160620029M , Exp. Date 5/31/2016 ; Service Code 2H8477 , Lot Number 160680044M , Exp. Date 6/6/2016 ; Service Code 2H8477 , Lot Number 160750038M , Exp. Date 6/13/2016 ; Service Code 2H8477 , Lot Number 160760128M , Exp. Date 6/14/2016 ; Service Code 2H8477 , Lot Number 160820118M , Exp. Date 6/21/2016 ; Service Code 2H8477 , Lot Number 160830037M , Exp. Date 6/22/2016 ; Service Code 2H8477 , Lot Number 160890044M , Exp. Date 6/27/2016 ; Service Code 2H8477 , Lot Number 160900040M , Exp. Date 6/28/2016 ; Service Code 2H8477 , Lot Number 160960037M , Exp. Date 7/4/2016 ; Service Code 2H8477 , Lot Number 160970136M , Exp. Date 7/6/2016 ; Service Code 2K8477 , Lot Number 160520174M , Exp. Date 5/22/2016 ; Service Code 2K8477 , Lot Number 160890053M , Exp. Date 6/27/2016 ; Service Code 2K8477 , Lot Number 160940139M , Exp. Date 7/3/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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