Premier Pharmacy Labs Recalls Mitomycin Due to Label Error
Premier Pharmacy Labs recalls 193 vials of Mitomycin 40 mg/mL irrigation due to a labeling error regarding the declared strength.
Recall notice
Labeling: Label Error on Declared Strength
Contact the company
What happened, in plain English
Premier Pharmacy Labs Inc is recalling one lot of Mitomycin 40 mg/mL Preservative Free Irrigation because the label incorrectly states the drug's strength. The recall affects 193 vials distributed nationwide. No remedy or specific health risks are detailed in the provided record. Read more at govinfonow.com/recall/40943-premier-pharmacy-labs-recalls-mitomycin-due-to-label-error.
Source Summary by GovInfoNow · govinfonow.com/recall/40943-premier-pharmacy-labs-recalls-mitomycin-due-to-label-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0251-2018
Cite this page
“Premier Pharmacy Labs Recalls Mitomycin Due to Label Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40943-premier-pharmacy-labs-recalls-mitomycin-due-to-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 hazard is a labeling error where the declared strength on the label does not match the actual content. This discrepancy could lead to incorrect dosing if used without verification, though the specific medical consequences are not described in the record.
Who’s affected
Healthcare providers and patients who received Mitomycin irrigation compounded by Premier Pharmacy Labs between the production date and the recall notice. The specific lot affected is MIT100217SVDS with a best-use date of 03/01/2018.
How to tell if you have this one
Check for Mitomycin 40 mg/mL Preservative Free Irrigation in 10 mL SDV vials. Look for NDC 69623-160-35 and Lot number MIT100217SVDS with a Best Use Date (BUD) of 03/01/2018.
- Brand
Premier Pharmacy Labs- Category
Drug
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 2.4 years 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.
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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 qwen3.6:35b-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.