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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

IntegraDose ceFAZolin Injections Recalled for Lack of Sterility Assurance

Agency Publication Date: September 30, 2021
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Summary

IntegraDose Compounding Services LLC has recalled 3,203 units of ceFAZolin injections, including 20 mL syringes and 115 mL bags, because they may not be sterile. The recall was initiated after a potential lack of sterility assurance was discovered. No injuries or illnesses have been reported to date, but these products were distributed to hospitals, pharmacies, and healthcare providers in New Hampshire, Massachusetts, and Minnesota.

Risk

Using a medication that is not sterile can result in serious or life-threatening infections. Because these medications are injected directly into the body, any bacterial or fungal contamination poses a significant health risk to patients.

What You Should Do

  1. This recall affects ceFAZolin 2 G/20 mL sterile syringes (NDC 71139-7087-1) and ceFAZolin 3 G in 0.9% Sodium Chloride 115 mL sterile bags (NDC 71139-7153-1).
  2. Check the product label for lot numbers and expiration dates. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection
Variants: 20 mL Syringe, 2 G / 20 mL
Lot Numbers:
20210803CEF-1 (Exp 09/17/2021)
20210805CEF-3 (Exp 09/19/2021)
20210806CEF-1 (Exp 09/20/2021)
20210806CEF-2 (Exp 09/20/2021)
20210809CEF-1 (Exp 09/23/2021)
20210809CEF-2 (Exp 09/23/2021)
20210810CEF-1 (Exp 09/24/2021)
20210811CEF-1 (Exp 09/25/2021)
20210812CEF-1 (Exp 09/26/2021)
NDC:
71139-7087-1

Manufactured at 719 Kasota Ave SE, Minneapolis, MN.

Product: ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection
Variants: 115 mL Bag, 3 G
Lot Numbers:
20210722CEF-2 (Exp 09/20/2021)
20210728CEF-1 (Exp 09/26/2021)
NDC:
71139-7153-1

Sterile Product manufactured at 719 Kasota Ave SE, Minneapolis, MN.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88731
Status: Resolved
Manufacturer: IntegraDose Compounding Services LLC
Sold By: Hospitals; Pharmacies; Healthcare Providers
Manufactured In: United States
Units Affected: 2 products (2,614 syringes; 589 bags)
Distributed To: New Hampshire, Massachusetts, Minnesota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.