Drug product
10 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 10 mL in 10 mL BD Syringe, Service Code 2T6203Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-203-27
D-1382-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 740 BD syringes
- Official record key
drug-enforcement:D-1382-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160380150M , Exp. Date 5/7/2016 ; Lot Number 160420180M , Exp. Date 5/11/2016 ; Lot Number 160450106M , Exp. Date 5/14/2016 ; Lot Number 160480109M , Exp. Date 5/17/2016 ; Lot Number 160660210M , Exp. Date 6/5/2016 ; Lot Number 160700121M , Exp. Date 6/8/2016 ; Lot Number 160770215M , Exp. Date 6/16/2016 ; Lot Number 160820099M , Exp. Date 6/20/2016 ; Lot Number 160880167M , Exp. Date 6/26/2016 ; Lot Number 161080045M , Exp. Date 7/16/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter