TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML
Medicine recall D-1629-2012. Published in FDA’s Enforcement Report on Aug 22, 2012.
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.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1603 units how much, in FDA’s words
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.
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.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 20MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 5ML VIAL 30MG / 2MG / 40MCG INJECTABLE 100 ML 5 ML 75 ML; TRIMIX 10MG / 0.5MG / 1MCG INJECTABLE 10 ML; TRIMIX 10MG / 1MG / 5MCG INJECTABLE 10 ML; TRIMIX 10MG/1MG/0.5MCG INJECTABLE 10 ML; TRIMIX 12.5MG/0.83MG/8.33MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 12MCG INJECTABLE 10 ML; TRIMIX 12MG / 1MG / 9MCG INJECTABLE 10 ML 10 MLS 20 ML 30 ML 5 ML; TRIMIX 12MG/1MG/5MCG INJECTABLE 10 ML; TRIMIX 15MG / 1MG / 10MCG INJECTABLE 3 ML 5 ML; TRIMIX 22.5MG/0.83MG/3MCG INJECTABLE 10 ML; TRIMIX 22.5MG/0.83MG/8.33MCG INJECTABLE 1 ML 10 ML 15 ML 2.5 ML 3 ML 30 ML 5 ML; TRIMIX 24MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 24MG / 1MG / 18MCG INJECTABLE 10 ML; TRIMIX 25MG/ 1MG / 10MCG INJECTABLE 10 ML; TRIMIX 28MG / 0.9MG / 37MCG INJECTABLE 5 ML; TRIMIX 30MG / 0.1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 10MCG INJECTABLE 10 ML; 120 ML 5 ML 60 MLS; TRIMIX 30MG / 0.5MG / 20MCG INJECTABLE 1.7 ML 10 ML 50 ML; TRIMIX 30MG / 0.5MG / 50MCG/ML INJECTABLE 10 ML; TRIMIX 30MG / 0.5MG / 5MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 10MG / 20MCG INJECTABLE 5 ML; TRIMIX 30MG / 10MG / 60MCG INJECTABLE 10 ML 10 MLS 20 ML 5 ML; TRIMIX 30MG / 1MG / 18MCG INJECTABLE 5 ML; TRIMIX 30MG / 1MG / 2.5MCG INJECTABLE 3 ML 5 ML; TRIMIX 30MG / 1MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 3 ML 5 ML; TRIMIX 30MG / 1MG / 30MCG INJECTABLE 10 ML 5 ML; TRIMIX 30MG / 1MG / 40MCG INJECTABLE 10 ML; TRIMIX 30MG / 1MG / 50MCG INJECTABLE 10 ML 10 MLS 100 ML 5 ML; TRIMIX 30MG / 1MG / 5MCG INJECTABLE 10 ML 20 ML 5 ML; TRIMIX 30MG / 2MG / 100MCG INJECTABLE 20 ML; TRIMIX 30MG / 2MG / 10MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 20MCG INJECTABLE 1 ML 10 ML 10 MLS 2 ML 2.5 ML 20 ML 3 ML 5 ML 5 MLS 6 ML 60 ML; TRIMIX 30MG / 2MG / 25MCG INJECTABLE 10 ML; TRIMIX 30MG / 2MG / 30MCG INJECTABLE 10 ML 10 MLS 5 ML; TRIMIX 30MG / 2MG / 3MCG INJECTABLE 5 ML; TRIMIX 30MG / 2MG / 40MCG INJECTABLE 1 ML 1.25 ML 10 ML 15 ML 2 ML 2.5 ML 20 ML 20 MLS 30 ML 4 ML 40 ML 5 ML 6 ML 60 ML; TRIMIX 30MG / 4MG / 3.5MCG INJECTABLE 10 ML
1603 units, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Rx #’s: 0370964 0392699 0399999 0388807 0373823 0407907 0408836 0409758 0368890 0396425 0404388 0390568 0393084 0390568 0353060 0390096 0369563 0356202 0399491 0377731 0365263 0398599 0400417 0409104 0381235 0355859 0371377 0402545 0371377…
Every code shown here, 2,000 characters
Rx #’s: 0370964 0392699 0399999 0388807 0373823 0407907 0408836 0409758 0368890 0396425 0404388 0390568 0393084 0390568 0353060 0390096 0369563 0356202 0399491 0377731 0365263 0398599 0400417 0409104 0381235 0355859 0371377 0402545 0371377 0404586 0359139 0375269 0380498 0390885 0371652 0371652 0370384 0390476 0357298 0381009 0389478 0400908 0391406 0388541 0390476 0389352 0403385 0390300 0391406 0380532 0371606 0392256 0364156 0402994 0407589 0369206 0378697 0388874 0391939 0399751 0409764 0357230 0401215 0393374 0401252 0403616 0407339 0381249 0393047 0399227 0373040 0410204 0353362 0367634 0380616 0387463 0395032 0396526 0400059 0403263 0403268 0408301 0385463 0409902 0395126 0399133 0401102 0401107 0401651 0403704 0405197 0405760 0406316 0406322 0396285 0403691 0397249 0359198 0407962 0362367 0403023 0405308 0371668 0351463 0355946 0358970 0367278 0368955 0378244 0378494 0381048 0381893 0382831 0389390 0392285 0392879 0394905 0403994 0358379 0375331 0374070 0398377 0368154 0374011 0376715 0382454 0382831 0399423 0399645 0401306 0391641 0402714 0408696 0394497 0409808 0406673 0375182 0393832 0391683 0368348 0375182 0385666 0391426 0367299 0408918 0360740 0375301 0391074 0392376 0397160 0398142 0399608 0402052 0402492 0377170 0385187 0352706 0355092 0356255 0356732 0358621 0363754 0364595 0365070 0365619 0366077 0367690 0369330 0369413 0369770 0371950 0372657 0373473 0374074 0374392 0374730 0374749 0377455 0378324 0379558 0380891 0381211 0382037 0382046 0382986 0383709 0384705 0385187 0386830 0386838 0386841 0387525 0388003 0388219 0388610 0389400 0389613 0389902 0390005 0390119 0390361 0390416 0390575 0390590 0392011 0393375 0393527 0393802 0393821 0394721 0395123 0395253 0395362 0395619 0396264 0396704 0396920 0397032 0397650 0397679 0397931 0398131 0398331 0398696 0399673 0399676 0399926 0400329 0400747 0400874 0401081 0401356 0401580 0402139 0402289 0402383 0402504 0402543 0403355 0403486 0403789 0403798 0403802 0404070 0404189 0404775 0404793 0405117 0405387…
FDA’s list runs to 10,351 characters. The first part is shown; the rest is on FDA’s record.
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.
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.
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.
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.
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 10,351 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.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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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.
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.