FDA recall D-0218-2017

Hospira Inc., A Pfizer Company · Class I · drug

Product

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Reason for recall

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2016-08-04
Report date: 2016-12-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0218-2017