Drug product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8103, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-103-48
D-1389-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 425 bags
- Official record key
drug-enforcement:D-1389-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160390174M , Exp. Date 5/9/2016 ; Lot Number 160400196M , Exp. Date 5/10/2016 ; Lot Number 160470128M , Exp. Date 5/17/2016 ; Lot Number 160530287M , Exp. Date 5/23/2016 ; Lot Number 160540190M , Exp. Date 5/24/2016 ; Lot Number 160590168M , Exp. Date 5/29/2016 ; Lot Number 160610129M , Exp. Date 5/31/2016 ; Lot Number 160680254M , Exp. Date 6/7/2016 ; Lot Number 160700199M , Exp. Date 6/9/2016 ; Lot Number 160750132M , Exp. Date 6/14/2016 ; Lot Number 160770177M , Exp. Date 6/16/2016 ; Lot Number 160810292M , Exp. Date 6/20/2016 ; Lot Number 160820115M , Exp. Date 6/21/2016 ; Lot Number 160840157M , Exp. Date 6/23/2016 ; Lot Number 160880249M , Exp. Date 6/27/2016 ; Lot Number 160890261M , Exp. Date 6/28/2016 ; Lot Number 160940057M , Exp. Date 7/2/2016 ; Lot Number 160960151M , Exp. Date 7/5/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter