Drug product
5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
D-1429-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 445 bags
- Official record key
drug-enforcement:D-1429-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Service Code 2H8477 , Lot Number 160400137M , Exp. Date 5/10/2016 ; Service Code 2H8477 , Lot Number 160450131M , Exp. Date 5/15/2016 ; Service Code 2H8477 , Lot Number 160470138M , Exp. Date 5/17/2016 ; Service Code 2H8477 , Lot Number 160480132M , Exp. Date 5/18/2016 ; Service Code 2H8477 , Lot Number 160550129M , Exp. Date 5/25/2016 ; Service Code 2H8477 , Lot Number 160610059M , Exp. Date 5/30/2016 ; Service Code 2H8477 , Lot Number 160620029M , Exp. Date 5/31/2016 ; Service Code 2H8477 , Lot Number 160680044M , Exp. Date 6/6/2016 ; Service Code 2H8477 , Lot Number 160750038M , Exp. Date 6/13/2016 ; Service Code 2H8477 , Lot Number 160760128M , Exp. Date 6/14/2016 ; Service Code 2H8477 , Lot Number 160820118M , Exp. Date 6/21/2016 ; Service Code 2H8477 , Lot Number 160830037M , Exp. Date 6/22/2016 ; Service Code 2H8477 , Lot Number 160890044M , Exp. Date 6/27/2016 ; Service Code 2H8477 , Lot Number 160900040M , Exp. Date 6/28/2016 ; Service Code 2H8477 , Lot Number 160960037M , Exp. Date 7/4/2016 ; Service Code 2H8477 , Lot Number 160970136M , Exp. Date 7/6/2016 ; Service Code 2K8477 , Lot Number 160520174M , Exp. Date 5/22/2016 ; Service Code 2K8477 , Lot Number 160890053M , Exp. Date 6/27/2016 ; Service Code 2K8477 , Lot Number 160940139M , Exp. Date 7/3/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter