CLASS II Drug recall · Reported 6 Oct 2021 · FDA Enforcement Report
ceFAZolin in 0.9% Sodium Chloride Bag for Injection recalled
IntegraDose Compounding Services is recalling ceFAZolin in 0.9% Sodium Chloride Bag for Injection, Sterile Product, IntegraDose, 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
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-0897-2021
- 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 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
Where it was distributed
NH, MA, MN
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lot, expiry: 20210722CEF-2, exp 09/20/2021; 20210728CEF-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 88731This product is part of a recall event; the main page for the event is ceFAZolin in Sterile Water Sterile Syringe for Injection recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ceFAZolin in Sterile Water Sterile Syringe for Injection recalled | IntegraDose Compounding Services | Sterility | MA, MN, NH |
More recalls from IntegraDose Compounding Services
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride, syringe recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS I | Oxytocin in 0.9% Sodium Chloride for intravenous use recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate 2,500 mcg/ in Sterile Water CADD recalled | IntegraDose Compounding Services | Sterility | Nationwide |
| Drug | 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 |
|---|---|---|---|---|---|
| Drug | CLASS I | Cefazolin in Dextrose, Injection recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
| Drug | CLASS II | ceFAZolin sodium in Sterile Water for injection recalled | Wells Pharma of Houston | Sterility | PA |
| Drug | CLASS II | Cefazolin 5mg/mL/Heparin/ml Syr, antibiotic recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Cefazolin for injection USP, and Dextrose Injection recalledCefazolin Sodium | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |