IntegraDose Compounding Services Recalls Cefazolin Injection Products

IPSIS Patient Safety Alert 09/22/2021: IntegraDose Compounding Services Recalls Cefazolin Injection Products

This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.

ISSUE: IntegraDose Compounding Services is recalling nine lots of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance.

Intravenous administration of a non-sterile drug could result in serious infections ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection which may be life-threatening. The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated. No batches of product have been identified as containing microorganisms.

To date, IntegraDose Compounding Services has not received reports of any adverse events associated with this issue for these lots.

For a list of recalled lots and product photos, click here.

BACKGROUND: Cefazolin is an antibiotic.

RECOMMENDATIONS: IntegraDose Compounding Services has notified its direct customers via a recall letter and is arranging for impacted product to be returned.

• Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately.

• Consumers with questions regarding this recall can contact IntegraDose Compounding Services.

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Adverse Event Reporting Program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178
  

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