CLASS III Drug recall · Reported 4 Apr 2018 · FDA Enforcement Report
Flucanazole Injection, USP 200 mg recalled by Renaissance Lakewood
Renaissance Lakewood is recalling Flucanazole Injection, USP 200 mg in (2 mg/mL) Dose Flexible Containers, distributed nationwide in the US. The recall was initiated on 2 Mar 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0605-2018
- FDA event ID
- 79310
- Recalling firm
- Renaissance Lakewood, Lakewood, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Mar 2018
- FDA classified
- 23 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Mar 2018 | Recall initiated by company | |
| 23 Mar 2018 | Classified by FDA | +21 days |
| 4 Apr 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 --- NDC 36000-006-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Which lots are affected?
Lot A060644, May 2018
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Renaissance Lakewood
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Packaging Defects | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, 2 mg/mL, a) recalled by Renaissance Lakewood | Renaissance Lakewood | Potency & Assay | Nationwide |