FDA recall D-0780-2016

Product

Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82

Reason for recall

Cross contamination with other products: metronidazole

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-03-01

Report date

2016-03-30

Termination date

2017-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Schaumburg, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0780-2016