Drug product
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
D-1428-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115 bags
- Official record key
drug-enforcement:D-1428-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160380152M , Exp. Date 5/8/2016 ; Lot Number 160400233M , Exp. Date 5/10/2016 ; Lot Number 160540186M , Exp. Date 5/24/2016 ; Lot Number 160660046M , Exp. Date 6/4/2016 ; Lot Number 160730154M , Exp. Date 6/12/2016 ; Lot Number 160750176M , Exp. Date 6/14/2016 ; Lot Number 160760046M , Exp. Date 6/14/2016 ; Lot Number 160800066M , Exp. Date 6/18/2016 ; Lot Number 160820111M , Exp. Date 6/20/2016 ; Lot Number 160960039M , Exp. Date 7/4/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter