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Renaissance Lakewood, LLC

Renaissance Lakewood, LLC Recalls

All product recalls associated with Renaissance Lakewood, LLC.

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Recall Summary

Total Recalls

6

Past Year

0

Class I (Serious)

0

Most Recent

Jul 2018

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–6 of 6 recalls

Fluconazole Injection (Renaissance Lakewood) – Superpotent Drug (2018)

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

FDAJul 11, 2018Nationwide• Renaissance Lakewood, LLC

Fluconazole Injection (Renaissance Lakewood) – Multiple Issues (2018)

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

FDAJul 11, 2018Nationwide• Renaissance Lakewood, LLC

Fluconazole Injection (Renaissance Lakewood) – Failed Stability (2018)

Failed Stability Specifications: lot out of specification for elevated water vapor.

Class III

Low

FDAJul 11, 2018Nationwide• Renaissance Lakewood, LLC

Flucanazole Injection (Renaissance) – Superpotent and Unstable (2018)

Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability

FDAMar 2, 2018Nationwide• Renaissance Lakewood, LLC

Fluconazole Injection (Renaissance) – Label Mix-up (2018)

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.

Class IIModerate

FDAFeb 21, 2018Nationwide• Renaissance Lakewood, LLC

Fluconazole Injection 2 mg/mL (Renaissance) – superpotent (2017)

Superpotent

FDANov 11, 2017Nationwide• Renaissance Lakewood, LLC