Hearth Record

MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML

Medicine recall D-1581-2012. Published in FDA’s Enforcement Report on Aug 22, 2012.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Aug 22, 2012. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Lack of Assurance of Sterility: Franck’s Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 0.5 ML 1 ML 1.5 ML 10 ML 12.5 ML 2 ML 2.5 ML 3 ML 30 ML 4 ML 5 ML 6 ML 7 ML; MITOMYCIN SOLUTION, STERILE 0.025% (250MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 6 ML MITOMYCIN SOLUTION, STERILE 0.03% (300MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 5 ML; MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC 1 ML 10 ML 12 ML 2 ML 20 ML 3 ML 3.6 ML 4 ML 5 ML 5.4 ML 6 ML 7.2 ML; MITOMYCIN SOLUTION, STERILE 0.05% (500MCG/ML) OPHTHALMIC 1.5 ML 10 ML 15 ML 2 ML 3 ML 5 ML; MITOMYCIN SOLUTION, STERILE/BUFFERED 0.5MG/ML INJECTABLE 80 ML; MITOMYCIN, LYOPHILIZED 1MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 3 VIAL 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 50 VIAL 6 VIAL 6 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 15 VIAL 16 VIAL 17 VIALS 18 VIAL 2 VIAL 20 VIAL 24 VIAL 24 VIALS 3 VIAL 30 VIAL 4 VIAL 5 VIAL 6 VIAL 6 VIALS 7 VIAL 7 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE 1 VIAL 1 VIALS 10 VIAL 10 VIALS 11 VIAL 12 VIAL 12 VIALS 13 VIAL 14 VIAL 15 `VIAL 15 VIAL 16 `VIAL 16 VIAL 17 `VIAL 18 VIAL 18 VIALS 2 `VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 23 `VIAL 23 VIAL 24 VIAL 3 VIAL 3 VIALS 30 VIAL 36 VIAL 4 VIAL 4 VIALS 40 VIAL 41 VIAL 5 VIAL 5 VIALS 50 VIAL 6 `VIAL 6 VIAL

1079 units, in FDA’s words.

Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Rx #’s: 0385634 0395331 0382740 0391178 0392393 0402036 0404974 0406412 0348990 0389957 0389256 0398308 0400088 0402379 0368830 0381744 0391578 0393939 0368830 0394696 0394699 0394702 0400088 0370658 0374176 0374332 0377853 0396389 0409606…

Every code shown here, 2,000 characters

Rx #’s: 0385634 0395331 0382740 0391178 0392393 0402036 0404974 0406412 0348990 0389957 0389256 0398308 0400088 0402379 0368830 0381744 0391578 0393939 0368830 0394696 0394699 0394702 0400088 0370658 0374176 0374332 0377853 0396389 0409606 0397569 0363591 0363906 0364885 0368563 0370643 0374134 0388160 0390765 0391578 0397626 0397664 0405185 0368830 0390948 0360900 0364885 0370658 0371998 0377418 0386488 0387749 0390765 0391251 0392700 0396481 0404354 0408442 0408450 0384787 0364885 0399054 0399978 0407186 0357229 0368830 0369658 0378021 0388340 0392613 0392899 0395705 0396389 0397569 0398713 0401967 0363906 0369658 0374332 0385847 0395772 0389236 0354926 0372478 0389236 0403647 0369615 0372478 0403647 0398727 0356719 0384919 0358078 0405425 0364078 0361229 0355028 0363367 0387510 0393522 0396503 0396748 0402531 0403762 0381124 0389376 0390757 0397155 0403061 0407722 0402531 0409835 0360794 0367718 0380495 0399205 0392377 0375206 0366326 0389376 0390757 0392377 0375206 0393522 0399205 0406462 0392377 0381206 0379957 0386978 0387228 0381206 0405721 0379957 0386978 0388312 0355234 0395430 0396345 0397113 0397206 0398817 0364094 0390534 0395074 0381540 0355612 0356043 0381225 0389512 0398817 0406027 0398694 0390534 0397464 0356043 0364094 0376377 0390194 0390768 0396674 0402214 0408184 0393442 0364094 0396343 0399934 0379020 0404494 0365952 0385380 0379020 0406986 0363729 0366561 0404494 0371056 0407417 0393442 0392768 0394298 0394606 0397253 0403210 0403347 0406699 0407892 0408311 0355056 0361444 0367534 0367592 0373176 0379506 0388023 0398878 0366168 0367534 0373176 0385023 0389065 0408083 0410227 0367592 0388249 0396642 0398122 0408087 0385991 0367534 0378631 0390829 0392453 0395572 0395650 0395824 0396106 0396417 0399802 0401313 0401636 0407069 0408311 0367592 0405638 0408667 0356337 0387887 0387973 0398326 0354974 0385991 0360653 0368998 0383647 0386367 0401638 0404139 0401960 0352358 0363847 0368488 0376511 0379506 0388170 0394298 0395650 0395898 0396265 0402035…

FDA’s list runs to 6,495 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on May 21, 2012.
  • FDA classified it on Aug 10, 2012.
  • FDA’s Enforcement Report published it on Aug 22, 2012.
  • FDA terminated it on Aug 15, 2014.
Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Franck’s Lab Inc., d.b.a. Franck’s Compounding Lab, of Ocala, FL.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • FDA’s list of codes runs to 6,495 characters; the first part is shown here, and the rest is on FDA’s record.
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Drug recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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