Drug product
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
D-1037-2016
Product summary
- Event
- Event 73935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69225 units
- Official record key
drug-enforcement:D-1037-2016
Official wording
Reason: Presence of Particulate Matter: Glass particulate found in sterile injectable product
Code information: Lot #: 6111504, Exp 09/2019
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter