Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible
Recalled August 8, 2018 · FDA recall D-1033-2018 · Renaissance Lakewood
Hazard
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. · FDA Class III
Units
12088 bags
Sold at
Nationwide and Puerto Rico
Description
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
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.
Manufacturer(s)
Renaissance Lakewood, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →