FDA recall D-1031-2018

Product

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.

Reason for recall

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-07-11

Report date

2018-08-08

Termination date

2022-03-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lakewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1031-2018