FDAFDA · Food and drugs·Recall number D-1414-2016
3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), 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 2H8180 , Lot Number 160450152M , Exp. Date 5/11/2016 ; Service Code 2H8180 , Lot Number 160830040M , Exp. Date 6/17/2016 ; Service Code 2H8262 , Lot Number 160380102M , Exp. Date 5/8/2016 ; Service Code 2H8262 , Lot Number 160750131M , Exp. Date 6/14/2016 ; Service Code 2H8262 , Lot Number 161080121M , Exp. Date 7/17/2016 ; Service Code 2K8180 , Lot Number 160460038C , Exp. Date 5/10/2016 ; Service Code 2K8180 , Lot Number 160480026C , Exp. Date 5/12/2016 ; Service Code 2K8180 , Lot Number 160550022C , Exp. Date 5/19/2016 ; Service Code 2K8180 , Lot Number 160620021C , Exp. Date 5/26/2016 ; Service Code 2K8180 , Lot Number 160680038C , Exp. Date 6/1/2016 ; Service Code 2K8180 , Lot Number 160760022C , Exp. Date 6/9/2016 ; Service Code 2K8180 , Lot Number 160770042C , Exp. Date 6/10/2016 ; Service Code 2K8180 , Lot Number 160830034C , Exp. Date 6/16/2016 ; Service Code 2K8180 , Lot Number 160900094C , Exp. Date 6/23/2016 ; Service Code 2K8180 , Lot Number 160940033C , Exp. Date 6/27/2016 ; Service Code 2K8180 , Lot Number 160970035C , Exp. Date 6/30/2016 ; Service Code 2K8905 , Lot Number 160810187M , Exp. Date 6/11/2016 ; Service Code 2K8905 , Lot Number 160890186M , Exp. Date 6/18/2016 ; Service Code 2K8975 , Lot Number 160550132M , Exp. Date 5/15/2016 ; Service Code 2K8975 , Lot Number 160610229M , Exp. Date 5/22/2016 ; Service Code 2K8975 , Lot Number 160770165M , Exp. Date 6/7/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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