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Renaissance Lakewood Recalls
6 recalls on record · December 27, 2017 to August 8, 2018 · Drugs
Recalls by year
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 8, 2018DrugsFDA
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
Hazard: Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
August 8, 2018DrugsFDA
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
Hazard: Failed Stability Specifications: lot out of specification for elevated water vapor.
August 8, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible
Hazard: Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
April 25, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx
Hazard: 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.
April 4, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for:
Hazard: Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
December 27, 2017DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactur
Hazard: Superpotent