FDAFDA · Food and drugs·Recall number D-1384-2016
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6733, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-733-20
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 2T6733 , Lot Number 160560088M , Exp. Date 5/25/2016 ; Service Code 2T6733 , Lot Number 160590097M , Exp. Date 5/28/2016 ; Service Code 2T6733 , Lot Number 160610032M , Exp. Date 5/31/2016 ; Service Code 2T6733 , Lot Number 160630191M , Exp. Date 6/2/2016 ; Service Code 2T6733 , Lot Number 160740251M , Exp. Date 6/13/2016 ; Service Code 2T6733 , Lot Number 160890051M , Exp. Date 6/27/2016 ; Service Code 2T6733 , Lot Number 160910161M , Exp. Date 6/29/2016 ; Service Code 2K8478 , Lot Number 160380039M , Exp. Date 5/8/2016 ; Service Code 2K8478 , Lot Number 160410139M , Exp. Date 5/11/2016 ; Service Code 2K8478 , Lot Number 160450247M , Exp. Date 5/15/2016 ; Service Code 2K8478 , Lot Number 160540145M , Exp. Date 5/24/2016 ; Service Code 2K8478 , Lot Number 160610157M , Exp. Date 5/31/2016 ; Service Code 2K8478 , Lot Number 160660142M , Exp. Date 6/5/2016 ; Service Code 2K8478 , Lot Number 160730262M , Exp. Date 6/12/2016 ; Service Code 2K8478 , Lot Number 160770247M , Exp. Date 6/16/2016 ; Service Code 2K8478 , Lot Number 160810195M , Exp. Date 6/20/2016 ; Service Code 2K8478 , Lot Number 160890161M , Exp. Date 6/28/2016 ; Service Code 2K8478 , Lot Number 160910234M , Exp. Date 6/30/2016 ; Service Code 2K8478 , Lot Number 160940235M , Exp. Date 7/3/2016 ; Service Code 2T8478 , Lot Number 160910132M , Exp. Date 5/7/2016 ; Service Code 2T8478 , Lot Number 160940032C , Exp. Date 5/10/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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