Lakewood, NJ, United States
Renaissance Lakewood, LLC recalls
3 recalls recorded since 2018, most recently on 11 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 11 July 2018
- Terminated
- 9 March 2022
- Reason
- Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
- Distribution
- Nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1033-2018, D-1031-2018, D-1032-2018
- Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By:
- Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By:
- Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By:
Terminated Class III Drugs
- Recall started
- 2 March 2018
- Terminated
- 10 April 2020
- Reason
- Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0605-2018
- Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India ---
Terminated Class II Drugs
- Recall started
- 21 February 2018
- Terminated
- 14 August 2019
- 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.
- Distribution
- Product was distributed throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0696-2018
- Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.