FDA Drug recall D-1031-2018
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
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class III recall of Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx… by Renaissance Lakewood, citing superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1031-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-07-11 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Renaissance Lakewood |
| Distribution | US |
Product
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: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
Reason
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Identifiers
| code_info | Lot # A061213, Exp 09/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Renaissance Lakewood
- 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 - 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 - 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 - 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 - 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
All Renaissance Lakewood recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1031-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.