Fresenius Kabi Recalls Sensorcaine-MPF Due to Glass Particles
Fresenius Kabi USA recalls Sensorcaine-MPF (Bupivacaine HCl) 0.75% vials due to glass particulate matter. Check lot #6111504.
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Presence of Particulate Matter: Glass particulate found in sterile injectable product
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What happened, in plain English
Fresenius Kabi USA, LLC is recalling Sensorcaine-MPF (Bupivacaine HCl Injection, USP), 0.75% in a 30 mL single-dose vial because glass particulate matter was found in the sterile injectable product. The recall affects 69,225 units distributed nationwide. This specific lot is identified as Lot #6111504 with an expiration date of 09/2019. Read more at govinfonow.com/recall/42861-fresenius-kabi-recalls-sensorcaine-mpf-due-to-glass-particles.
Source Summary by GovInfoNow · govinfonow.com/recall/42861-fresenius-kabi-recalls-sensorcaine-mpf-due-to-glass-particles · Updated October 11, 2026 · FDA enforcement record: FDA #D-1037-2016
Cite this page
“Fresenius Kabi Recalls Sensorcaine-MPF Due to Glass Particles.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42861-fresenius-kabi-recalls-sensorcaine-mpf-due-to-glass-particles. Based on FDA recall #D-1037-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1037-2016%22&limit=1).
Why it’s dangerous
The presence of glass particulate matter in a sterile injectable product poses a serious health risk. If injected, these particles can cause embolisms, tissue damage, or other severe complications within the patient's body.
Who’s affected
Healthcare providers and patients who received or used Sensorcaine-MPF injection from the recalled lot. Patients are at risk if the glass particles enter their body during administration.
How to tell if you have this one
Look for Sensorcaine-MPF (Bupivacaine HCl Injection, USP), 0.75% in a 30 mL single-dose vial. Check the label for NDC 63323-472-37 and Lot #6111504. The product was distributed nationwide.
- Brand
Fresenius Kabi- Category
Drug
What to do — step by step
Stop Using Recalled Vials
Do not use any vials matching the recalled lot number or NDC code.
Contact Healthcare Provider
If you have used this product, consult your healthcare provider immediately for guidance on potential health impacts.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What NDC code identifies this recall?
The National Drug Code (NDC) is 63323-472-37.
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Where this comes from
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.
- Official source: FDA Recall #D-1037-2016 (April 25, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1037-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.