Drug product
5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8256, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-256-50 ,
D-1422-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 655 bags
- Official record key
drug-enforcement:D-1422-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Service Code 2H8256 , Lot Number 160410124M , Exp. Date 5/11/2016 ; Service Code 2H8256 , Lot Number 160560146M , Exp. Date 5/26/2016 ; Service Code 2H8256 , Lot Number 160590041M , Exp. Date 5/29/2016 ; Service Code 2H8256 , Lot Number 160690131M , Exp. Date 6/8/2016 ; Service Code 2H8256 , Lot Number 160900157M , Exp. Date 6/29/2016 ; Service Code 2K8254 , Lot Number 160390176M , Exp. Date 5/9/2016 ; Service Code 2K8254 , Lot Number 160410129M , Exp. Date 5/11/2016 ; Service Code 2K8254 , Lot Number 160460130M , Exp. Date 5/16/2016 ; Service Code 2K8254 , Lot Number 160530293M , Exp. Date 5/23/2016 ; Service Code 2K8254 , Lot Number 160590075M , Exp. Date 5/29/2016 ; Service Code 2K8254 , Lot Number 160600187M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160610002M , Exp. Date 5/30/2016 ; Service Code 2K8254 , Lot Number 160680155M , Exp. Date 6/6/2016 ; Service Code 2K8254 , Lot Number 160760125M , Exp. Date 6/14/2016 ; Service Code 2K8254 , Lot Number 160880192M , Exp. Date 6/27/2016 ; Service Code 2K8254 , Lot Number 160890178M , Exp. Date 6/28/2016 ; Service Code 2K8256 , Lot Number 160480195M , Exp. Date 5/12/2016 ; Service Code 2K8256 , Lot Number 160530189M , Exp. Date 5/17/2016 ; Service Code 2K8256 , Lot Number 160560081M , Exp. Date 5/19/2016 ; Service Code 2K8256 , Lot Number 160590069M , Exp. Date 5/23/2016 ; Service Code 2K8256 , Lot Number 160660151M , Exp. Date 5/30/2016 ; Service Code 2K8256 , Lot Number 160680250M , Exp. Date 6/1/2016 ; Service Code 2K8256 , Lot Number 160880025M , Exp. Date 6/20/2016 ; Service Code 2K8256 , Lot Number 160950047M , Exp. Date 6/27/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter