Drug product
2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K8433, NDC 61553-433-58, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
D-1397-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 bags
- Official record key
drug-enforcement:D-1397-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160470226M , Exp. Date 5/11/2016 ; Lot Number 160540237M , Exp. Date 5/18/2016 ; Lot Number 160600045M , Exp. Date 5/23/2016 ; Lot Number 160750052M , Exp. Date 6/7/2016 ; Lot Number 160950043M , Exp. Date 6/27/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter