FDAFDA · Food and drugs·Recall number D-1409-2016
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
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 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 ; Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 ; Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 ; Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 ; Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 ; Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 ; Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 ; Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 ; Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 ; Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 ;
- 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.