CLASS II Drug recall · Reported 6 Oct 2021 · FDA Enforcement Report

ceFAZolin in Sterile Water Sterile Syringe for Injection recalled

IntegraDose Compounding Services is recalling ceFAZolin in Sterile Water Sterile Syringe for Injection, IntegraDose Compounding, distributed in Massachusetts, Minnesota, New Hampshire. The recall was initiated on 17 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021

Quantity recalled2,614 syringes

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-0896-2021
FDA event ID: 88731
Recalling firm: IntegraDose Compounding Services, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2021
FDA classified: 30 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

17 Sep 2021	Recall initiated by company
30 Sep 2021	Classified by FDA	+13 days
6 Oct 2021	Published in enforcement report	+6 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 sterility assurance.

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

ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1

Where it was distributed

NH, MA, MN

Massachusetts Minnesota New Hampshire

Questions about this recall

Why was it recalled?

Lack of sterility assurance.

Which lots are affected?

Lot, expiry: Lot 20210803CEF-1, exp 09/17/2021; Lot 20210805CEF-3, 09/19/2021; Lots 20210806CEF-1, 20210806CEF-2, exp 09/20/2021; Lots 20210809CEF-1, 20210809CEF-2, exp 09/23/2021; Lot 20210810CEF-1, exp 09/24/2021; Lot 20210811CEF-1, exp 09/25/2021; Lot 20210812CEF-1, exp 09/26/2021

Where was it sold?

NH, MA, MN

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

1 other product · FDA event 88731

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021	CLASS II	ceFAZolin in 0.9% Sodium Chloride Bag for Injection recalled	IntegraDose Compounding Services	Sterility	MA, MN, NH

More recalls from IntegraDose Compounding Services

All 8

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Vasopressin in 0.9% Sodium Chloride, syringe recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
27 May 2026Drug	CLASS II	fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS I	Oxytocin in 0.9% Sodium Chloride for intravenous use recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
10 Apr 2024Drug	CLASS II	fentaNYL Citrate 2,500 mcg/ in Sterile Water CADD recalled	IntegraDose Compounding Services	Sterility	Nationwide
21 Feb 2024Drug	CLASS II	Vasopressin in 0.9% Sodium Chloride Sterile Syringe recalled	IntegraDose Compounding Services	Potency & Assay	MN

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