Fresenius Kabi recalls Xylocaine-MPF with Epinephrine 1:200,000 injection due to low epinephrine assay results. This may affect medical use safety. Check vial NDC 63323-487-07 or tray NDC 63323-487-37 for affected units.
Low out of specification results for epinephrine assay.
Fresenius Kabi is recalling Xylocaine-MPF with Epinephrine 1:200,000 injections because the epinephrine content may be too low. This could lead to ineffective pain relief during medical procedures, though serious injury risks are not described in the recall.
The epinephrine assay results are below the specified level, meaning the injection may not contain enough epinephrine to work effectively. This could result in inadequate pain control during medical procedures. However, the recall does not indicate a risk of serious injury or death.
Healthcare providers using this injection for medical procedures. Patients receiving the injection under a doctor's supervision are most at risk if the epinephrine level is too low.
Check for vial NDC 63323-487-07 or tray NDC 63323-487-37. The product was sold with batch numbers 6123435, 6124730, 6124731 expiring January 2022 or July 2022.
Identify the vial NDC 63323-487-07 or tray NDC 63323-487-37 to confirm if your product is affected.
The recall states low epinephrine assay results, but it does not indicate that the product is unsafe. It may not work as intended for pain relief.
The recall does not specify a remedy, so no action is required. Check the product details to see if it matches the affected units.
Look for vial NDC 63323-487-07 or tray NDC 63323-487-37 with batch numbers 6123435, 6124730, or 6124731 expiring January 2022 or July 2022.
We’ve drafted a message you can send Fresen:ius Kabi to request your refund or repair — edit it as you like.
Subject: Recall D-0651-2021 — Fresen:ius Kabi Fresen:ius Kabi Hello, I own a Fresen:ius Kabi that is covered by recall D-0651-2021 from Fresen:ius Kabi. 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.
