FDA recall D-0453-2018

Product

Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.

Reason for recall

Lack of sterility assurance.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2017-12-27

Report date

2018-02-28

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0453-2018