Drug product
2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
D-1402-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95 bags
- Official record key
drug-enforcement:D-1402-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Service Code 2H8103 , Lot Number 160450153M , Exp. Date 5/11/2016 ; Service Code 2K8444 , Lot Number 160490047C , Exp. Date 5/13/2016 ; Service Code 2K8444 , Lot Number 160540031C , Exp. Date 5/18/2016 ; Service Code 2K8444 , Lot Number 160610039C , Exp. Date 5/25/2016 ; Service Code 2K8444 , Lot Number 160730032C , Exp. Date 6/6/2016 ; Service Code 2K8444 , Lot Number 160760038C , Exp. Date 6/9/2016 ; Service Code 2K8444 , Lot Number 160800049C , Exp. Date 6/13/2016 ; Service Code 2K8444 , Lot Number 160960053C , Exp. Date 6/29/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter