Premier Pharmacy Labs Inc recalls Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265
Premier Pharmacy Labs recalls 10mL Mitomycin 40 mg/mL irrigation due to labeling error on declared strength. This may cause incorrect dosing if used without verification.
Lower-risk recall
Labeling: Label Error on Declared Strength
Contact the company & request your remedy
What happened, in plain English
Premier Pharmacy Labs is recalling 10mL Mitomycin 40 mg/mL irrigation products compounded by their pharmacy because the label shows the wrong strength. This could lead to incorrect dosing if someone uses the product without checking the label carefully. Read more at govinfonow.com/recall/40943-premier-pharmacy-labs-mitomycin-40-mg-ml-irrigation-label-error.
Source Summary by GovInfoNow · govinfonow.com/recall/40943-premier-pharmacy-labs-mitomycin-40-mg-ml-irrigation-label-error · Updated October 7, 2026 · FDA enforcement record: FDA #D-0251-2018
Cite this page
“Premier Pharmacy Labs Mitomycin 40 mg/mL Irrigation: Label Error on Strength.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40943-premier-pharmacy-labs-mitomycin-40-mg-ml-irrigation-label-error. Based on FDA recall #D-0251-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0251-2018%22&limit=1).
Why it’s dangerous
The label shows an incorrect declared strength, which could lead to improper dosing if the product is used without verifying the correct concentration. This is a labeling error, not a safety hazard in normal use.
Who’s affected
Patients using this specific irrigation solution for medical purposes. Those who have the product with the lot number MIT100217SVDS are most at risk.
How to tell if you have this one
Check for the product name 'Mitomycin 40 mg/mL Preservative Free Irrigation', volume 10 mL, compounded by Premier Pharmacy Labs 8265. The lot number MIT100217SVDS and expiration date 03/01/2018 are specific identifiers.
- Brand
Premier Pharmacy Labs- Category
Drug
What to do — step by step
Verify Label Strength
Check the label for the declared strength of the solution. If it shows a different concentration than what was intended, do not use it.
Questions people ask
Is this product dangerous to use?
No, this is a labeling error that could lead to incorrect dosing if not verified, but it does not pose a direct safety risk in normal use.
What should I do if I have this product?
Check the label for the declared strength. If it shows a different concentration than what was intended, do not use it. Otherwise, it is safe to use with proper verification.
How can I tell if I have the recalled product?
Look for the product name 'Mitomycin 40 mg/mL Preservative Free Irrigation', volume 10 mL, compounded by Premier Pharmacy Labs 8265 with lot number MIT100217SVDS.
Contact Premier Pharmacy Labs
We’ve drafted a message you can send Premier Pharmacy Labs to request your refund or repair — edit it as you like.
Subject: Recall D-0251-2018 — Premier Pharmacy Labs Premier Pharmacy Labs Hello, I own a Premier Pharmacy Labs that is covered by recall D-0251-2018 from Premier Pharmacy Labs. 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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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-0251-2018 (January 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0251-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.