CLASS II Drug recall · Reported 5 Apr 2017 · FDA Enforcement Report
Fluconazole Injection, USP, 400 mg recalled by Claris Lifesciences
Claris Lifesciences is recalling Fluconazole Injection, USP, 400 mg, distributed nationwide in the US. The recall was initiated on 10 Mar 2017 and the FDA has classified it as Class II.
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-0614-2017
- FDA event ID
- 76733
- Recalling firm
- Claris Lifesciences, North Brunswick, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2017
- FDA classified
- 24 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Mar 2017 | Recall initiated by company | |
| 24 Mar 2017 | Classified by FDA | +14 days |
| 5 Apr 2017 | 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
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Which lots are affected?
Lot #: A051052, Exp. Aug 2017
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
3 other products · FDA event 76733| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Levofloxacin Injection in 5% Dextrose, 750 mg in 5% Dextrose recalledLevofloxacin | Claris Lifesciences | Sterility | Nationwide | |
| CLASS II | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 5% Dextrose recalled | Claris Lifesciences | Sterility | Nationwide | |
| CLASS II | Metronidazole Injection, USP, 500 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |
More recalls from Claris Lifesciences
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 5% Dextrose recalled | Claris Lifesciences | Potency & Assay | Nationwide |
| Drug | CLASS II | Metronidazole Injection, USP, 500 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |
| Drug | CLASS II | Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 5% Dextrose recalled | Claris Lifesciences | Sterility | Nationwide |
| Drug | CLASS II | Levofloxacin Injection in 5% Dextrose, 750 mg in 5% Dextrose recalledLevofloxacin | Claris Lifesciences | Sterility | Nationwide |
Other Fluconazole recalls
All 22| 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 |