Safety Report: Cefazolin - recalled due to Lack of sterility assurance., USA

United States

Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, 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 resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.

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 products, while not confirmed, cannot be eliminated. No batches of the 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.

- Cefazolin 2 gram in 20 mL syringe for injection. (See link below for a detailed list of Lots)
- Cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection. (See link below for a detailed list of Lots)

Cefazolin is an antibiotic and the products are packaged in zip-locking bags containing ten units. The lots were distributed nationwide in the USA to hospitals from 8/12/21 to 9/15/21. IntegraDose Compounding Services has initiated an investigation to determine the root cause and corrective and preventative actions.

IntegraDose Compounding Services has notified its direct customers via a recall letter and is arranging for the 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 by phone at (612-672-5216) on Monday - Friday, 8:00 AM – 4:00 PM CDT.

Company name: IntegraDose Compounding Services, LLC
Brand name: IntegraDose Compounding Services, LLC
Product recalled: Cefazolin
Reason of the recall: Lack of sterility assurance.
FDA Recall date: September 21, 2021

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/integradose-compounding-services-llc-issues-voluntary-nationwide-recall-cefazolin-injection-products

Source: FDA