FDAFDA · Food and drugs·Recall number D-1428-2016
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
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 160380152M , Exp. Date 5/8/2016 ; Lot Number 160400233M , Exp. Date 5/10/2016 ; Lot Number 160540186M , Exp. Date 5/24/2016 ; Lot Number 160660046M , Exp. Date 6/4/2016 ; Lot Number 160730154M , Exp. Date 6/12/2016 ; Lot Number 160750176M , Exp. Date 6/14/2016 ; Lot Number 160760046M , Exp. Date 6/14/2016 ; Lot Number 160800066M , Exp. Date 6/18/2016 ; Lot Number 160820111M , Exp. Date 6/20/2016 ; Lot Number 160960039M , Exp. Date 7/4/2016 ;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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