Drug product
10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H9155, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 3614, NDC 61553-1552-52
D-1379-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 750 bags
- Official record key
drug-enforcement:D-1379-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160460017C , Exp. Date 5/12/2016 ; Lot Number 160600019C , Exp. Date 5/26/2016 ; Lot Number 160670016C , Exp. Date 6/2/2016 ; Lot Number 160740027C , Exp. Date 6/9/2016 ; Lot Number 160810024C , Exp. Date 6/16/2016 ; Lot Number 160880005C , Exp. Date 6/23/2016 ; Lot Number 160950036M , Exp. Date 6/29/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter