Drug product
5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48
D-1421-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,256 Medical Cassettes
- Official record key
drug-enforcement:D-1421-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Lot Number 160460023M , Exp. Date 5/7/2016 ; Lot Number 160460024M , Exp. Date 5/7/2016 ; Lot Number 160460025M , Exp. Date 5/7/2016 ; Lot Number 160460328M , Exp. Date 5/7/2016 ; Lot Number 160540052M , Exp. Date 5/15/2016 ; Lot Number 160600338M , Exp. Date 5/21/2016 ; Lot Number 160600339M , Exp. Date 5/21/2016 ; Lot Number 160600340M , Exp. Date 5/21/2016 ; Lot Number 160600341M , Exp. Date 5/21/2016 ; Lot Number 160680065C , Exp. Date 5/29/2016 ; Lot Number 160750039C , Exp. Date 6/5/2016 ; Lot Number 160750040C , Exp. Date 6/5/2016 ; Lot Number 160750041C , Exp. Date 6/5/2016 ; Lot Number 160770040C , Exp. Date 6/7/2016 ; Lot Number 160880030C , Exp. Date 6/18/2016 ; Lot Number 160880031C , Exp. Date 6/18/2016 ; Lot Number 160880032C , Exp. Date 6/17/2016 ; Lot Number 160880033C , Exp. Date 6/18/2016 ; Lot Number 160880034C , Exp. Date 6/18/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter