SCA Pharmaceuticals recalls fentanyl 500 mcg/100mL injections due to lack of sterility assurance. This affects specific lots manufactured between 2022-2023. Patients should contact their healthcare provider for guidance.
Lack of Assurance of Sterility
SCA Pharmaceuticals is recalling fentanyl 500 mcg/100mL injections that may not be sterile. This could lead to infections if used improperly. The recall affects specific lots with expiration dates through November 2023.
The product lacks assurance of sterility, meaning it could contain harmful bacteria. If used, this might cause serious infections or other health complications.
Patients prescribed this injection for epidural use. Healthcare providers who administer the medication are most at risk.
Check the product label for the lot number 1223048722 (expires 11/29/23) or 1223049096 (expires 12/15/23). The product is only available by prescription and for epidural use.
Since the recall involves prescription medication, patients should contact their healthcare provider for guidance on next steps.
The recall indicates a lack of sterility assurance, so it is not safe to use without consulting a healthcare provider.
Contact your healthcare provider for instructions on how to handle the recalled product.
Look for lot numbers 1223048722 (expires 11/29/23) or 1223049096 (expires 12/15/23) on the product label.
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0401-2024 — SCA Pharmaceuticals SCA Pharmaceuticals Hello, I own a SCA Pharmaceuticals that is covered by recall D-0401-2024 from SCA Pharmaceuticals. 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.
