Drug product
2 mcg/mL Fentanyl Citrate and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8095, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-095-50 ,
D-1390-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 bags
- Official record key
drug-enforcement:D-1390-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160390213M , Exp. Date 5/9/2016 ; Lot Number 160420162M , Exp. Date 5/12/2016 ; Lot Number 160480197M , Exp. Date 5/18/2016 ; Lot Number 160600057M , Exp. Date 5/29/2016 ; Lot Number 161080145M , Exp. Date 7/17/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter