IntegraDose recalls specific lots of ceFAZolin 2g/20mL in sterile water for injection due to lack of sterility assurance. Affected products may cause infection if used.
Lack of sterility assurance.
IntegraDose is recalling certain lots of ceFAZolin 2g/20mL in sterile water for injection because the product may not be sterile. Using these products could lead to infections.
The product lacks sterility assurance, meaning it may contain contaminants that could cause infections when injected. This risk is present in the specific lots listed in the recall.
Patients who received the recalled lots of ceFAZolin 2g/20mL in sterile water for injection from IntegraDose. Those with medical conditions requiring injections are at higher risk.
Check the product label for the lot numbers: 20210803CEF-1 through 20210812CEF-1. The expiration dates range from September 17, 2021, to September 26, 2021.
Look for the lot numbers listed in the recall: 20210803CEF-1 through 20210812CEF-1.
The recall states the product may not be sterile, so it is not safe to use. Affected lots should be discarded.
Check the product label for lot numbers 20210803CEF-1 through 20210812CEF-1 with expiration dates from September 17, 2021, to September 26, 2021.
Discard the product immediately as it may not be sterile and could cause infection.
We’ve drafted a message you can send IntegraDose to request your refund or repair — edit it as you like.
Subject: Recall D-0896-2021 — IntegraDose IntegraDose Hello, I own a IntegraDose that is covered by recall D-0896-2021 from IntegraDose. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
