CLASS II Drug recall · Reported 5 Apr 2017 · FDA Enforcement Report
Metronidazole Injection, USP, 500 mg recalled by Claris Lifesciences
Claris Lifesciences is recalling Metronidazole Injection, USP, 500 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-0616-2017
- 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
- Antibiotics
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
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
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 #: A060205; A060209, Exp.Jan 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 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 76733This product is part of a recall event; the main page for the event is Fluconazole Injection, USP, 400 mg recalled by Claris Lifesciences.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fluconazole Injection, USP, 400 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide | |
| 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 |
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 | 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 |
| Drug | CLASS II | Fluconazole Injection, USP, 400 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |
Other Metronidazole recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metronidazole 500MG, antibiotic recalled by Sentara Infusion Services | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Metronidazole Vaginal Gel USP, 0.75% with 5 applicators recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metronidazole tablets, USP 250 mg unit dose recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metronidazole 500mg Tablet recalled by Safecor Health | Safecor Health | Manufacturing (CGMP) Deviations | MA, NY |
| Drug | CLASS II | Metronidazole 1% Gel, Metronidazole 1%/ Niacinamide recalled | Synergy Rx | Sterility | Nationwide |