Assurance Infusion recalls BUP 15MG/HYDROM 5MG/ML in 20mL syringes due to lack of sterility assurance. Affected lots: 12122019@20, expiring 12/21/2019.
Lack of sterility assurance.
Assurance Infusion is recalling BUP 15MG/HYDROM 5MG/ML injection in 20mL syringes because they lack sterility assurance. This could lead to infections if used improperly.
The syringes lack sterility assurance, meaning they might not be clean enough to prevent infections. This could cause serious infections if used for injections.
People who own or use this specific syringe product are affected. Those with medical conditions requiring injections may be at higher risk.
Check for the lot number 12122019@20 on the syringe packaging. The expiration date is 12/21/2019.
Look for the lot number 12122019@20 and expiration date 12/21/2019 on the syringe packaging.
The recall states there is a lack of sterility assurance, so it is not safe to use.
The recall does not specify a remedy, so check with Assurance Infusion at (713) 533-8800 for guidance.
Look for the lot number 12122019@20 and expiration date 12/21/2019 on the syringe packaging.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0686-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0686-2020 from Assurance Infusion. 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.
