Drug product
2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98
D-1400-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 480 bags
- Official record key
drug-enforcement:D-1400-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160480033C , Exp. Date 5/12/2016 ; Lot Number 160520027C , Exp. Date 5/16/2016 ; Lot Number 160610040C , Exp. Date 5/25/2016 ; Lot Number 160750051C , Exp. Date 6/8/2016 ; Lot Number 160800038C , Exp. Date 6/13/2016 ; Lot Number 160880045C , Exp. Date 6/21/2016 ; Lot Number 160940037C , Exp. Date 6/27/2016 ; Lot Number 160960035C , Exp. Date 6/29/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter