BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML
Medicine recall D-1466-2012. 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
- 448 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 because 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?
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BIMIX 26MG/1MG/ML INJECTABLE 10 ML; BIMIX 26MG/2MG/ML INJECTABLE 20 ML; BIMIX 30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML; BIMIX 30MG / 1.5MG INJECTABLE 5 ML; BIMIX 30MG/1MG INJECTABLE 1 ML, 10 ML, 10 MLS, 12 ML, 150 ML, 2 ML, 20 ML, 20 MLS, 3 ML, 30 ML, 40 ML, 5 ML, 5 MLS, 50 ML, 6 ML, 60 ML, 7 ML; BIMIX 9MG / 0.5MG/ML INJECTABLE 5 ML; BIMIX 15MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 16.6MG / 0.55MG/ML INJECTABLE 10 ML, 4.5 ML; BIMIX 30MG / 2MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG/3MG/ML INJECTABLE 10 ML, 5 ML; BIMIX 40MG/2MG INJECTABLE 10 ML, 3 ML, 6 ML; BIMIX 40MG/3MG INJECTABLE 3 ML; BIMIX, SDSM 9MG / 0.25MG INJECTABLE 10 ML; BIMIX, SDSM 9MG / 0.5MG INJECTABLE 10 ML; BIMIX, SDSM 18MG / 0.5MG INJECTABLE 10 ML, 10 MLS; BIMIX, SDSM 30MG / 1.5MG INJECTABLE 10 ML, 10 MLS, 5 ML, 5 MLS; BIMIX, SDSM 30MG / 1MG INJECTABLE 10 ML, 5 ML (58 DIFFERENT PRODUCTS)
448 units, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Rx #’s: 0384355, 0389246, 0392332, 0399800, 0407377, 0385460, 0389158, 0402762, 0385460, 0359057, 0385462, 0396242, 0385462, 0391321, 0372399, 0400437, 388360, 0350745, 0354900, 0357950, 0365803, 0391686, 0393285, 0393620, 0395404,…
Every code shown here, 2,000 characters
Rx #’s: 0384355, 0389246, 0392332, 0399800, 0407377, 0385460, 0389158, 0402762, 0385460, 0359057, 0385462, 0396242, 0385462, 0391321, 0372399, 0400437, 388360, 0350745, 0354900, 0357950, 0365803, 0391686, 0393285, 0393620, 0395404, 0399228, 0399302, 0401675, 0401844, 0403731, 0406162, 0408427, 0409073, 0399228, 0371562, 0376422, 0396380, 0405576, 0405582, 0405586, 0384289, 0366702, 0360431, 0408278, 0390548, 0396007, 0401479, 0352078, 0352368, 0354526, 0354595, 0357480, 0358685, 0359207, 0363768, 0364549, 0368498, 0369212 0373766 0374428 0375279 0375571 0375873 0377397 0380000 0380005 0381659 0382914 0384657 0386665 0387419 0387519 0387699 0388026 0388292 0388330 0388766 0389900 0390082 0390315 0391607 0392449 0392525 0392848 0393087 0393381 0393499 0393828 0393904 0394395 0394985 0395878 0395912 0396010 0396019 0396120 0396163 0396207 0396267 0396366 0396906 0397063 0397523 0397527 0397728 0398291 0398862 0399237 0399251 0399644 0399898 0401001 0401380 0401414 0401480 0401858 0401991 0402382 0402634 0403182 0403417 0404396 0404958 0404962 0404965 0405377 0405697 0406246 0406753 0406809 0407466 0407512 0407521 0407830 0408706 0408768 0408828 0409007 0409150 0409158 0409809 0388728 0409113 0395179 0401812 0380005 0390728 0408848 0357188 0380005 0388326 0388531 0398590 0407315 0359319 0379979 0380005 0398376 0406549 0390081 0390728 0406512 0350594 0351237 0354526 0358579 0358794 0361059 0362431 0363752 0367108 0367355 0368710 0369213 0369806 0369811 0370264 0370618 0373793 0375571 0378322 0378326 0378513 0378942 0379218 0379983 0380003 0380005 0380149 0382749 0383556 0386269 0386665 0387095 0387179 0387861 0388633 0388634 0388636 0388637 0388638 0388641 0388894 0389374 0389385 0389548 0389790 0390777 0390779 0390781 0390782 0390784 0390790 0392100 0392378 0392380 0392388 0392390 0392508 0392649 0393106 0393111 0393112 0393114 0393115 0393117 0393118 0393836 0393838 0393839 0393841 0393843 0393846 0393848 0394141 0394181 0395615 0395620 0395622 0395623 0395625 0395628…
FDA’s list runs to 3,255 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, and 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 25, 2012.
- FDA classified it on Aug 10, 2012.
- FDA’s Enforcement Report published it on Aug 22, 2012.
- FDA terminated it on Aug 13, 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 3,255 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.