CLASS I Drug recall · Reported 6 May 2020 · FDA Enforcement Report
Ceftazidime for Injection USP and Dextrose recalled by B. Braun Medical
B. Braun Medical is recalling Ceftazidime for Injection USP and Dextrose for Injection USP Duplex Container, distributed nationwide in the US. The recall was initiated on 18 Apr 2020 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-1257-2020
- FDA event ID
- 85507
- Recalling firm
- B. Braun Medical, Irvine, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 18 Apr 2020
- FDA classified
- 28 Apr 2020
- Reported
- 6 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Apr 2020 | Recall initiated by company | |
| 28 Apr 2020 | Classified by FDA | +10 days |
| 6 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
Where it was distributed
Product was distributed nationwide within the United States.
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Which lots are affected?
Lot #: H8J812, Exp. Date 31 JUL 2020
Where was it sold?
Product was distributed nationwide within the United States.
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
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | 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 Ceftazidime recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ceftazidime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Ceftazidime, 2.25mg/, Injectable plastic syringe, RX recalled | Oregon Compounding Centers | Sterility | OR, WA |
| Drug | CLASS II | Ceftazidime, 22.5 mg/ml (ophthalmic) recalled by Specialty Medicine | Specialty Medicine Compounding Pharmacy | Sterility | MI |
| Drug | CLASS II | Ceftazidime Ophthalmic, P.f. 22.5mg/ML (2.25%) Ophthalmic recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |