FDAFDA · Food and drugs·Recall number D-1398-2016
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
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 160380168M , Exp. Date 5/8/2016 ; Lot Number 160410137M , Exp. Date 5/11/2016 ; Lot Number 160460150M , Exp. Date 5/16/2016 ; Lot Number 160530279M , Exp. Date 5/23/2016 ; Lot Number 160590185M , Exp. Date 5/29/2016 ; Lot Number 160630160M , Exp. Date 6/2/2016 ; Lot Number 160680179M , Exp. Date 6/7/2016 ; Lot Number 160730238M , Exp. Date 6/12/2016 ; Lot Number 160840215M , Exp. Date 6/23/2016 ; Lot Number 160880193M , Exp. Date 6/27/2016 ; Lot Number 160890187M , Exp. Date 6/28/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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