Renaissance Lakewood recalls
Renaissance Lakewood appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2018-08-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2017-12-27 to 2018-08-08 |
| By agency | FDA Drug (6) |
| By classification | Class III (5), Class II (1) |
| By status | terminated (6) |
| Distribution named in notices | US |
Recalls
- Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx…
FDA Drug · Class III · 2018-08-08 · Renaissance Lakewood
Reason: Failed Stability Specifications: lot out of specification for elevated water vapor. - Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx…
FDA Drug · Class III · 2018-08-08 · Renaissance Lakewood
Reason: Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay. - Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx…
FDA Drug · Class III · 2018-08-08 · Renaissance Lakewood
Reason: Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor. - Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured…
FDA Drug · Class II · 2018-04-25 · Renaissance Lakewood
Reason: 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. - Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifescience…
FDA Drug · Class III · 2018-04-04 · Renaissance Lakewood
Reason: Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability - Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeS…
FDA Drug · Class III · 2017-12-27 · Renaissance Lakewood
Reason: Superpotent