Assurance Infusion recalls HYDROM 10MG/SUF 200MCG/ML injections in 20mL syringes due to lack of sterility assurance. Affected lots: 12112019@4, expiration 12/20/2019.
Lack of sterility assurance.
Assurance Infusion is recalling HYDROM 10MG/SUF 200MCG/ML injections in 20mL syringes because they may not be sterile. This could lead to infections if used improperly.
The injections may not be sterile, which can cause infections if the product is used. This is a serious risk for medical treatments where sterility is critical.
People who have received this specific injection product, particularly those using it for medical treatments. Those with compromised immune systems may be at higher risk.
Check for the lot number 12112019@4 on the syringe packaging. The expiration date is December 20, 2019.
Look for the lot number 12112019@4 and expiration date of December 20, 2019 on the syringe packaging.
The recall indicates a lack of sterility assurance, so it is not safe to use. The product should be discarded.
Check the lot number and expiration date. If it matches the recalled lot (12112019@4) and expires by December 20, 2019, contact Assurance Infusion at (713) 533-8800 to report it.
The recall record does not mention a replacement option. Contact Assurance Infusion at (713) 533-8800 for further assistance.
We’ve drafted a message you can send Assurance Infusion to request your refund or repair — edit it as you like.
Subject: Recall D-0737-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0737-2020 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.
