FDAFDA · Food and drugs·Recall number D-1402-2016
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), 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 2H8103 , Lot Number 160450153M , Exp. Date 5/11/2016 ; Service Code 2K8444 , Lot Number 160490047C , Exp. Date 5/13/2016 ; Service Code 2K8444 , Lot Number 160540031C , Exp. Date 5/18/2016 ; Service Code 2K8444 , Lot Number 160610039C , Exp. Date 5/25/2016 ; Service Code 2K8444 , Lot Number 160730032C , Exp. Date 6/6/2016 ; Service Code 2K8444 , Lot Number 160760038C , Exp. Date 6/9/2016 ; Service Code 2K8444 , Lot Number 160800049C , Exp. Date 6/13/2016 ; Service Code 2K8444 , Lot Number 160960053C , Exp. Date 6/29/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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