Drug product
2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
D-1404-2016
Product summary
- Event
- Event 74057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 Medical Cassettes
- Official record key
drug-enforcement:D-1404-2016
Official wording
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Code information: Service Code 2K8892 , Lot Number 160560168M , Exp. Date 5/17/2016 ; Service Code 2K8892 , Lot Number 160810001M , Exp. Date 6/10/2016 ; Service Code 2K8219 , Lot Number 160530297M , Exp. Date 5/23/2016 ;
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter