Renaissance Lakewood recalls
FDA enforcement reports naming Renaissance Lakewood, LLC as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Aug 8, 2018
- Aug 8, 2018Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg…Drug · Renaissance Lakewood, LLCSuperpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.Class III
- Aug 8, 2018Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg…Drug · Renaissance Lakewood, LLCFailed Stability Specifications: lot out of specification for elevated water vapor.Class III
- Aug 8, 2018Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg…Drug · Renaissance Lakewood, LLCSuperpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.Class III
- Apr 25, 2018Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg…Drug · Renaissance Lakewood, LLCLabeling: 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.Class II
- Apr 4, 2018Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Conta…Drug · Renaissance Lakewood, LLCSuperpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeabilityClass III
- Dec 27, 2017Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33…Drug · Renaissance Lakewood, LLCSuperpotentClass III