CLASS I Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Cefepime for Injection USP and Dextrose Injection recalled
B. Braun Medical is recalling Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System in, distributed nationwide in the US. The recall was initiated on 15 Oct 2013 and the FDA has classified it as Class I.
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-1054-2014
- FDA event ID
- 66497
- Recalling firm
- B. Braun Medical, Irvine, CA
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Oct 2013
- FDA classified
- 31 Jan 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Oct 2013 | Recall initiated by company | |
| 31 Jan 2014 | Classified by FDA | +108 days |
| 12 Feb 2014 | 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
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Product as listed by the FDA
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Which lots are affected?
Lot H3A744, Exp 01/15
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 B. Braun Medical
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|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
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| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
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Other Cefepime recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefepime for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Cefepime for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Cefepime for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Cefepime for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Cefepime for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |