CLASS II Drug recall · Reported 10 Jul 2013 · FDA Enforcement Report
Metronidazole Injection USP, RTU, 500 mg recalled by Baxter Healthcare
Baxter Healthcare is recalling Metronidazole Injection USP, RTU, 500 mg/ in Viaflex Plus Container, Baxter, Deerfield, distributed nationwide in the US. The recall was initiated on 21 May 2013 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-629-2013
- FDA event ID
- 65288
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Metronidazole
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2013
- FDA classified
- 28 Jun 2013
- Reported
- 10 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 21 May 2013 | Recall initiated by company | |
| 28 Jun 2013 | Classified by FDA | +38 days |
| 10 Jul 2013 | 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: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
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, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48
Where it was distributed
Nationwide & Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Which lots are affected?
Lot #: P280123, P280123A, Exp 2/14
Where was it sold?
Nationwide & Puerto Rico
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
5 other products · FDA event 65288This product is part of a recall event; the main page for the event is Sodium Chloride Injection, USP, a) recalled by Baxter Healthcare.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sodium Chloride Injection, USP, a) recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Sterility | Nationwide | |
| CLASS II | Lidocaine Hydrochloride and 5% Dextrose Injection, USP Viaflex Plus recalled | Baxter Healthcare | Packaging Defects | Nationwide | |
| CLASS II | 5% Dextrose Injection, USP, in Viaflex Multi Pack recalledDextrose | Baxter Healthcare | Sterility | Nationwide | |
| CLASS II | 0.9% Sodium Chloride Injection recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Sterility | Nationwide | |
| CLASS II | Heparin Sodium and 0.9% Sodium Chloride Injection, a) recalledHeparin Sodium In Sodium Chloride | Baxter Healthcare | Sterility | Nationwide |
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | 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 Injection, USP, 500 mg recalled by Claris Lifesciences | Claris Lifesciences | Sterility | Nationwide |