CLASS II Drug recall · Reported 22 Feb 2023 · FDA Enforcement Report
Metronidazole 500MG, antibiotic recalled by Sentara Infusion Services
Sentara Infusion Services is recalling Metronidazole 500MG, antibiotic, distributed nationwide in the US. The recall was initiated on 27 Dec 2022 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-0306-2023
- FDA event ID
- 91466
- Recalling firm
- Sentara Infusion Services, Chesapeake, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2022
- FDA classified
- 15 Feb 2023
- Reported
- 22 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 27 Dec 2022 | Recall initiated by company | |
| 15 Feb 2023 | Classified by FDA | +50 days |
| 22 Feb 2023 | Published in enforcement report | +7 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 sterility assurance
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 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Where it was distributed
Dispensed to Patients Nationwide.
Questions about this recall
Is Metronidazole 500MG, antibiotic recalled?
Yes. Sentara Infusion Services recalled Metronidazole 500MG, antibiotic on 27 Dec 2022. The recall is Class II and its status is Terminated. Recall number D-0306-2023.
Why was it recalled?
Lack of sterility assurance
Which lots are affected?
Beyond Use Date: December 24-29, 2022
Where was it sold?
Dispensed to Patients 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 21 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 Sentara Infusion Services
All 53| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Intralipid 18gm, Tpn recalled by Sentara Infusion Services | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Amikacin 450MG IN NS, Antibiotic, used in a Homepump recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin 12GM IN NS 600M, used with a Curlin pump recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP, (b)90GM/AA recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Daptomycin (a) 400MG IN NS, (b) 550MG IN NS, antibiotic recalled | Sentara Infusion Services | Sterility | Nationwide |