CLASS I Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Cefazolin for Injection USP and Dextrose Injection recalled
B. Braun Medical is recalling Cefazolin for Injection USP and Dextrose Injection USP in Duplex Container, distributed nationwide in the US. The recall was initiated on 21 Nov 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-1269-2014
- FDA event ID
- 66913
- Recalling firm
- B. Braun Medical, Irvine, CA
- Brand
- Cefazolin Sodium
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Nov 2013
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Nov 2013 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +155 days |
| 7 May 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: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Product as listed by the FDA
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11
Where it was distributed
Nationwide, Puerto Rico and Spain
Questions about this recall
Is Cefazolin for Injection USP and Dextrose Injection USP in Duplex Container recalled?
Yes. B. Braun Medical recalled Cefazolin for Injection USP and Dextrose Injection USP in Duplex Container on 21 Nov 2013. The recall is Class I and its status is Terminated. Recall number D-1269-2014.
Why was it recalled?
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Which lots are affected?
Lot# H2S723, Exp 07/14; H3H711, Exp 01/15
Where was it sold?
Nationwide, Puerto Rico and Spain
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 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 B. Braun Medical
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
| Drug | ANNOUNCED | B. Braun 9% Sodium Chloride Injection USP, in a PAB Container recalledB. Braun | B. Braun Medical | Particulate Matter | Nationwide |
| 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 |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Cefazolin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Sterility | Nationwide |
| Drug | CLASS II | Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cefazolin for Injection, USP per vial recalled by Cardinal HealthCefazolin | Cardinal Health | Sterility | FL, GA, SC |
| Drug | CLASS I | Cefazolin for Injection USP and Dextrose Injections recalledCefazolin Sodium | B. Braun Medical | Particulate Matter | Nationwide |