Drug product
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
D-1418-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 455 bags
- Official record key
drug-enforcement:D-1418-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Service Code 2H8126 , Lot Number 161080146M , Exp. Date 7/17/2016 ; Service Code 2K8127 , Lot Number 160460115M , Exp. Date 5/10/2016 ; Service Code 2K8127 , Lot Number 160560222M , Exp. Date 5/20/2016 ; Service Code 2K8127 , Lot Number 160610209M , Exp. Date 5/25/2016 ; Service Code 2K8127 , Lot Number 160620148M , Exp. Date 5/26/2016 ; Service Code 2K8127 , Lot Number 160660062M , Exp. Date 5/29/2016 ; Service Code 2K8127 , Lot Number 160680154M , Exp. Date 6/1/2016 ; Service Code 2K8127 , Lot Number 160690126M , Exp. Date 6/2/2016 ; Service Code 2K8127 , Lot Number 160740153M , Exp. Date 6/7/2016 ; Service Code 2K8127 , Lot Number 160800064M , Exp. Date 6/12/2016 ; Service Code 2K8127 , Lot Number 160810161M , Exp. Date 6/14/2016 ; Service Code 2K8127 , Lot Number 160880187M , Exp. Date 6/21/2016 ; Service Code 2K8127 , Lot Number 160950226M , Exp. Date 6/28/2016 ; Service Code 2K8127 , Lot Number 160960154M , Exp. Date 6/29/2016 ; Service Code 2K8211 , Lot Number 160530215M , Exp. Date 5/23/2016 ; Service Code 2K8211 , Lot Number 160590067M , Exp. Date 5/29/2016 ; Service Code 2K8211 , Lot Number 160750033M , Exp. Date 6/13/2016 ; Service Code 2K8211 , Lot Number 160880261M , Exp. Date 6/27/2016 ; Service Code 2K8211 , Lot Number 160910039M , Exp. Date 6/29/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter