Drug product
16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free), 1.5 mL in 3 mL BD Syringe, Service Code 2T6228, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-228-96
D-1388-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 230 BD syringes
- Official record key
drug-enforcement:D-1388-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160410126M , Exp. Date 5/10/2016 ; Lot Number 160450114M , Exp. Date 5/14/2016 ; Lot Number 160460158M , Exp. Date 5/15/2016 ; Lot Number 160670040M , Exp. Date 6/5/2016 ; Lot Number 160730148M , Exp. Date 6/12/2016 ; Lot Number 160840112M , Exp. Date 6/22/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter