Drug product
1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
D-1373-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 Medical Cassettes
- Official record key
drug-enforcement:D-1373-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160630037M , Exp. Date 5/23/2016 ; Lot Number 160640007M , Exp. Date 5/24/2016 ; Lot Number 160700207M , Exp. Date 5/31/2016 ; Lot Number 160730149M , Exp. Date 6/3/2016 ; Lot Number 160830163M , Exp. Date 6/12/2016 ; Lot Number 160880258M , Exp. Date 6/18/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter