FDA recall D-1033-2018

Product

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.

Reason for recall

Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

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-1033-2018