FDA recall D-0333-2019

Product

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.

Reason for recall

Sub-potent

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-12-05

Report date

2018-12-26

Termination date

2020-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0333-2019