FDA recall D-0002-2015

Hospira Inc. · Class I · drug

Product

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29

Reason for recall

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-06-17
Report date: 2014-10-08
Termination date: 2017-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0002-2015