Renaissance Lakewood Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg recall — FDA D-1033-2018
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Overview of recall records associated with Renaissance Lakewood, LLC, including dates, categories and classifications where available.
Classification mix: Class III: 4, Class II: 1.
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Failed Stability Specifications: lot out of specification for elevated water vapor.
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
This page summarizes recall records in which the official source identifies Renaissance Lakewood, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.