Cefazolin Recalled Due to Potentially ‘Life-Threatening’ Infections
According to a news report on miamiherald.com, the U.S. Food and Drug Administration reported that eleven lots of the intravenous antibiotic Cefazolin were recalled due to a lack of sterility assurance. The manufacturer of the recalled Cefazolin, IntegraDose Compounding Services, reported that the sterility assurance issue was caused during the compounding process that did not complete dynamic smoke study testing.
In the company’s FDA-posted recall alert, compounded drugs that combine two or more drugs are not FDA regulated. Intravenous administration of any medication that is not sterile can cause serious life-threatening infections such as bacterial meningitis, septicemia, and wound infections.
The lots of Cefazolin that have been recalled include:
Cefazolin 2 gram in 20 mL syringe for injection lot Numbers:
- 20210803CEF-1, expiration 9/17/2021;
- 20210805CEF-3, expiration 9/19/2021;
- 20210806CEF-1 and 20210806CEF-2, expiration 9/20/2021;
- 20210809CEF-1 and 20210809CEF-2, expiration 9/23/2021;
- 20210810CEF-1, expiration 9/24/2021;
- 20210811CEF-1, expiration 9/25/2021; and
- 20210812CEF-1, expiration 9/26/2021.
Cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection:
- 20210722CEF-2, expiration 9/20/2021; and
- 20210728CEF-1, expiration 9/26/2021.
The Cefazolin products were delivered to hospitals throughout the United States from August 12, 2021 through September 15, 2021.
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