IntegraDose Compounding Services Issues Voluntary Nationwide Recall of Cefazolin Injection Products Because of a Lack of Sterility Assurance
On September 21, 2021, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/integradose-compounding-services-llc-issues-voluntary-nationwide-recall-cefazolin-injection-products) IntegraDose Compounding Services’ voluntary recall of nine lots of cefazolin 2 g in 20 ml syringe for injection and two lots of cefazolin 3 g in 100 ml 0.9% sodium chloride bag for injection because of a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.
Cefazolin is an antibiotic, and the products are packaged in zip-top bags containing 10 units. The recall affects lots that were shipped nationwide to hospitals from August 12–September 15, 2021. FDA said IntegraDose Compounding Services has initiated an investigation to determine the root cause and take corrective and preventative actions.
IV administration of a nonsterile drug could result in complications ranging from serious infections (e.g., fever, chills, malaise) to severe adverse events (e.g., septicemia, bacterial meningitides, wound infection), which may be life-threatening. FDA reported that to date, no batches of product have been identified as containing microorganisms and IntegraDose Compounding Services has not received reports of any adverse events associated with this issue for these lots.
The recall affects the following lots of cefazolin:
|
Product |
National Drug Code |
Lot |
Expiration Date |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210803CEF-1 |
9/17/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210805CEF-3 |
9/19/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210806CEF-1 |
9/20/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210806CEF-2 |
9/20/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210809CEF-1 |
9/23/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210809CEF-2 |
9/23/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210810CEF-1 |
9/24/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210811CEF-1 |
9/25/2021 |
|
Cefazolin 2 g in 20 ml syringe for injection |
71139-7087-1 |
20210812CEF-1 |
9/26/2021 |
|
Cefazolin 3 g in 100 ml 0.9% sodium chloride bag for injection |
71139-7053-1 |
20210722CEF-2 |
9/20/2021 |
|
Cefazolin 3 g in 100 ml 0.9% sodium chloride bag for injection |
71139-7053-1 |
20210728CEF-1 |
9/26/2021 |
IntegraDose Compounding Services sent a recall letter to customers and arranged for the affected product to be returned. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately.
Consumers who have questions should contact their physician or healthcare provider and IntegraDose Compounding Services at 612-672-5216, Monday–Friday from 8 am–4 pm (CDT), or at celse1@fairview.org (mailto:celse1@fairview.org).
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experience while using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.