Drug product
2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H9195, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-195-50
D-1403-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 105 bags
- Official record key
drug-enforcement:D-1403-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160890247M , Exp. Date 6/28/2016 ; Lot Number 160380151M , Exp. Date 5/8/2016 ; Lot Number 160490238M , Exp. Date 5/19/2016 ; Lot Number 160550208M , Exp. Date 5/25/2016 ; Lot Number 160610062M , Exp. Date 5/30/2016 ; Lot Number 160630184M , Exp. Date 6/2/2016 ; Lot Number 160700191M , Exp. Date 6/9/2016 ; Lot Number 160750045M , Exp. Date 6/13/2016 ; Lot Number 160770156M , Exp. Date 6/16/2016 ; Lot Number 160910163M , Exp. Date 6/30/2016 ; Lot Number 160810279M , Exp. Date 6/20/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter