FDA recall D-0334-2019

Product

Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48

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-0334-2019