Assurance Infusion recalls BUP 30mg/ Hydrom 10mg/ml 20mL syringes due to lack of sterility assurance. Affected lots: 12122019@23 exp 12/21/2019. No remedy specified in recall notice.
Lack of sterility assurance.
Assurance Infusion is recalling BUP 30mg/ Hydrom 10mg/ml 20mL syringes because they lack sterility assurance. This could lead to infections if used improperly. The recall affects specific lots with an expiration date of December 21, 2019.
The syringes lack sterility assurance, meaning they could be contaminated with bacteria or other pathogens. If used for injections, this could lead to infections or other health complications. The hazard is specific to the manufacturing process and not a general issue with the product.
Patients using the recalled syringes for medical injections are affected. Healthcare providers who have these syringes in their inventory may also be impacted.
Check for the lot number 12122019@23 on the syringe packaging. The expiration date is December 21, 2019. The product is labeled as BUP 30mg/ Hydrom 10mg/ml in a 20mL syringe.
Look for the lot number 12122019@23 and expiration date of December 21, 2019 on the syringe packaging.
The recall notice does not specify any remedy.
The expiration date is December 21, 2019.
Check for the lot number 12122019@23 and expiration date of December 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-0700-2020 — Assurance Infusion Assurance Infusion Hello, I own a Assurance Infusion that is covered by recall D-0700-2020 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.
