Drug product
3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97
D-1413-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 bags
- Official record key
drug-enforcement:D-1413-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160420248M , Exp. Date 5/6/2016 ; Lot Number 160490250M , Exp. Date 5/13/2016 ; Lot Number 160600329M , Exp. Date 5/24/2016 ; Lot Number 160620002M , Exp. Date 5/25/2016 ; Lot Number 160660181M , Exp. Date 5/30/2016 ; Lot Number 160760025M , Exp. Date 6/9/2016 ; Lot Number 160870159M , Exp. Date 6/20/2016 ; Lot Number 160940170M , Exp. Date 6/27/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter