CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride recalled

Leiter's Compounding is recalling Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) Total Volume in a Vial, distributed nationwide in the US. The recall was initiated on 20 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll unexpired lots; Expirations dates of 09/24/2016 to 02/06/2017

Quantity recalled76,315 total units, all products

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-0012-2017
FDA event ID: 75230
Recalling firm: Leiter's Compounding, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Sep 2016
FDA classified: 12 Oct 2016
Reported: 19 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

20 Sep 2016	Recall initiated by company
12 Oct 2016	Classified by FDA	+22 days
19 Oct 2016	Published in enforcement report	+7 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 Assurance of Sterility; all compounded products within expiry produced using recalled filters

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

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters

Which lots are affected?

All unexpired lots; Expirations dates of 09/24/2016 to 02/06/2017

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 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.

Other products in this recall event

8 other products · FDA event 75230

This product is part of a recall event; the main page for the event is Cyclopentolate HCl 1% - Tropicamide recalled by Leiter's Compounding.

Reported	Class	Recall	Company	Reason	Where
19 Oct 2016	CLASS II	Cyclopentolate HCl 1% - Tropicamide recalled by Leiter's Compounding	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016	CLASS II	Placebo for Prednisolone Acetate 1%, Oph Suspension Dropper recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016	CLASS II	Atropine Sulfate 0.01% in 0.9% Sodium Chloride recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016	CLASS II	Brilliant Blue G 0.025% in 0.9% Sodium Chloride recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016	CLASS II	Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016	CLASS II	Vancomycin 10 mg/mL in 0.9% Sodium Chloride recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016	CLASS II	Lidocaine HCl 1% - Phenylephrine HCl recalled by Leiter's Compounding	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016	CLASS II	Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection recalled	Leiter's Compounding	Sterility	Nationwide

More recalls from Leiter's Compounding

All 9

Reported	Class	Recall	Company	Reason	Where
19 Oct 2016Drug	CLASS II	Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	Lidocaine HCl 1% - Phenylephrine HCl recalled by Leiter's Compounding	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	Vancomycin 10 mg/mL in 0.9% Sodium Chloride recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution recalled	Leiter's Compounding	Sterility	Nationwide
19 Oct 2016Drug	CLASS II	Brilliant Blue G 0.025% in 0.9% Sodium Chloride recalled	Leiter's Compounding	Sterility	Nationwide

Other Cefuroxime recalls

All 6

Reported	Class	Recall	Company	Reason	Where
25 Oct 2023Drug	CLASS II	Cefuroxime 4mg / (10 mg/mL) syringe recalled by Pine Pharmaceuticals	Pine Pharmaceuticals	Sterility	Nationwide
2 Feb 2022Drug	CLASS II	Cefuroxime, Sterile Ophthalmic Solution for Injection recalled	Edge Pharma	Sterility	Nationwide
10 Apr 2019Drug	CLASS II	Cefuroxime 10mg/mL INJ 0.5 mg, SDV recalled	Pacific Compounding Pharmacy & Consultations	Particulate Matter	CA
13 Mar 2019Drug	CLASS II	Cefuroxime 10 mg/mL in Sodium Chloride recalled by Leiter's Enterprises	Leiter's Enterprises	Sterility	4 states
7 Feb 2018Drug	CLASS III	Cefuroxime, Ophthalmic Solution for Injection recalled	JCB Laboratories	Potency & Assay	Nationwide