CLASS II Drug recall · Reported 1 Mar 2017 · FDA Enforcement Report
METRONIDazole Injection, USP 500 mg (5 mg/mL) recalled
Hospira Inc. A Pfizer is recalling METRONIDazole Injection, USP 500 mg (5 mg/mL) in Single Dose Flexible Container, distributed nationwide in the US. The recall was initiated on 10 Feb 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-0480-2017
- FDA event ID
- 76460
- Recalling firm
- Hospira Inc. A Pfizer, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2017
- FDA classified
- 17 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 10 Feb 2017 | Recall initiated by company | |
| 17 Feb 2017 | Classified by FDA | +7 days |
| 1 Mar 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 Sterility Assurance: customer report of leaking bag
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 (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Sterility Assurance: customer report of leaking bag
Which lots are affected?
Lot: 54-054-JT, 6/1/2017
Where was it sold?
Nationwide and 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.
More recalls from Hospira Inc. A Pfizer
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|---|---|---|---|---|---|
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| Drug | CLASS III | Argatroban Injection, 250 mg/ (100 mg/mL) Single-use vial recalled | Hospira Inc. A Pfizer | Potency & Assay | Nationwide |
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| Drug | CLASS I | Vancomycin Hydrochloride for Injection, USP, Pharmacy recalled | Hospira Inc. A Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS I | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) recalledBupivacaine Hydrochloride | Hospira Inc. A Pfizer | 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 |