Drug product
2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8297, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-297-02
D-1407-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 380 bags
- Official record key
drug-enforcement:D-1407-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160530277M , Exp. Date 5/17/2016 ; Lot Number 160610199M , Exp. Date 5/25/2016 ; Lot Number 160660176M , Exp. Date 5/30/2016 ; Lot Number 160690200M , Exp. Date 6/2/2016 ; Lot Number 160770187M , Exp. Date 6/10/2016 ; Lot Number 160890268M , Exp. Date 6/22/2016 ; Lot Number 160960227M , Exp. Date 6/29/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter