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
FDA recall notice · announced June 22, 2016 · Fresenius Kabi
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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
Reason for recall
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Notes
Distribution: Nationwide
Lot/code information: Lot #: 6111504, Exp 09/2019
Quantity: 69225 units
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.