FDA recall D-0203-2017

Product

Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75

Reason for recall

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-11-18

Report date

2016-12-21

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0203-2017