Drug product
2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02
D-1401-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 bags
- Official record key
drug-enforcement:D-1401-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160420104M , Exp. Date 5/6/2016 ; Lot Number 160450187M , Exp. Date 5/9/2016 ; Lot Number 160530126M , Exp. Date 5/17/2016 ; Lot Number 160680200M , Exp. Date 6/1/2016 ; Lot Number 160730047M , Exp. Date 6/5/2016 ; Lot Number 160750130M , Exp. Date 6/8/2016 ; Lot Number 160830227M , Exp. Date 6/16/2016 ; Lot Number 160870077M , Exp. Date 6/19/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter