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

Lot, batch or date codesLot# H2S723, Exp 07/14; H3H711, Exp 01/15

NDC0264-3103, 0264-3105, 0264-3107

Quantity recalled42,576 units

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

Nationwide Puerto Rico

Questions about this recall

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 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.

Other products in this recall event

11 other products · FDA event 66913

This product is part of a recall event; the main page for the event is Cefoxitin for Injection and Dextrose Injection in Duplex Container recalled.

Reported	Class	Recall	Company	Reason	Where
7 May 2014	CLASS I	Cefoxitin for Injection and Dextrose Injection in Duplex Container recalledCefoxitin And Dextrose	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	Cefazolin for Injection USP and Dextrose Injections recalledCefazolin Sodium	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	Cefepime for Injections USP and Dextrose Injection recalledCefepime Hydrochloride And Dextrose	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	0.9 % Sodium Chloride Injection recalled by B. Braun Medical	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	0.9 % Sodium Chloride Injection USP in PAB partial fill recalledSodium Chloride	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	TrophAmine (10% Amino Acid Injection) Container recalled	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	15% Amino Acids Injection PBP Glass recalled by B. Braun Medical	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	ProcalAmine (3% Amino Acid and 3% Glycerin Injection recalled	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	6.9% FreAmine HBC (Amino Acid Injection) recalled by B. Braun Medical	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	Hyperlyte CR (Multi-Electrolyte Concentrate) Container recalled	B. Braun Medical	Particulate Matter	Nationwide
7 May 2014	CLASS I	Ceftriaxone for Injection and Dextrose Injection in Duplex Container recalled	B. Braun Medical	Particulate Matter	Nationwide

More recalls from B. Braun Medical

All 447

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS II	Sesk Upmc Double Catheter Tray recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

Other Cefazolin recalls

All 15

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS I	Cefazolin in Dextrose, Injection recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
9 Jul 2025Drug	CLASS I	Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin	Sandoz	Packaging Defects	Nationwide
13 Dec 2023Drug	CLASS II	ceFAZolin sodium in Sterile Water for injection recalled	Wells Pharma of Houston	Sterility	PA
22 Feb 2023Drug	CLASS II	Cefazolin 5mg/mL/Heparin/ml Syr, antibiotic recalled	Sentara Infusion Services	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide