Mitomycin Preservative Free Irrigation recalls

The FDA has published 1 recall involving Mitomycin Preservative Free Irrigation since 2019. The latest was reported on 3 Jul 2019. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Jul 2019

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why mitomycin preservative free irrigation is recalled

Sterility1100%

Companies

Premier Pharmacy Labs1100%

By year

20191100%

All mitomycin preservative free irrigation recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
3 Jul 2019Drug	CLASS II	Mitomycin Preservative Free Irrigation, 40mg/ (4mg/mL) SDV recalled	Premier Pharmacy Labs	Sterility	Nationwide

Should you stop taking Mitomycin Preservative Free Irrigation?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.