FDA recall D-1037-2016

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-04-25

Report date

2016-06-22

Termination date

2016-10-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1037-2016