WATER BACT STERILE
Medicine recall D-1643-2012. 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
- 311 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?
WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100 ML 100 MLS 1000 ML 110 ML 120 ML 130 ML 130 MLS 150 150 ML 150 MLS 160 ML 160 MLS 20 20 ML 200 ML 200 MLS 2000 ML 230 ML 240 ML 250 ML 250 MLS 30 ML 30 MLS 300 300 ML 300 MLS 40 ML 40 MLS 400 ML 400 MLS 50 50 ML 50 MLS 500 ML 500 MLS 60 60 ML 60 MLS 6800 ML 70 ML 7240 ML 7500 ML 80 ML 80 MLS 90 ML; WATER STERILE - USP (25X20ML)** INJECTABLE 1000 MLS 200 ML 200 MLS 300 MLS 400 MLS 500 ML 60 60 ML 600 20 600 ML; WATER STERILE - USP (25X50ML)** INJECTABLE 1000 ML 1150 ML 1250 MLS 1350 ML 150 MLS 2500 ML 300 ML 50 ML 500 ML 500 MLS 600 600 ML 600 MLS (72 DIFFERENT PRODUCTS)
311 units, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Rx #’s: 0408845 0400308 0404146 0404314 0404734 0405632 0406573 0406701 0407236 0407894 0409557 0408043 0408222 0403792 0404381 0404597 0404937 0405274 0405602 0405880 0405881 0405889 0406307 0406538 0406558 0407551 0410050 0410051 0410054…
Every code shown here, 2,000 characters
Rx #’s: 0408845 0400308 0404146 0404314 0404734 0405632 0406573 0406701 0407236 0407894 0409557 0408043 0408222 0403792 0404381 0404597 0404937 0405274 0405602 0405880 0405881 0405889 0406307 0406538 0406558 0407551 0410050 0410051 0410054 0410335 0403801 0404660 0405429 0406714 0404383 0404424 0404429 0404431 0408668 0404381 0405641 0403996 0404175 0404381 0404598 0404985 0405057 0405274 0405520 0405687 0406286 0406538 0406573 0406905 0407288 0408084 0408783 0408855 0410229 0410380 0404381 0409102 0404479 0405889 0404597 0404661 0404881 0405520 0405836 0405881 0406558 0405174 0404381 0406372 0407748 0405429 0403860 0403862 0404014 0404169 0404533 0404735 0405599 0405896 0406440 0406612 0406750 0407072 0407940 0408312 0408462 0408930 0409264 0410399 0404881 0405639 0405654 0405882 0405883 0406752 0407396 0404682 0408308 0404383 0404381 0404328 0406996 0409438 0404660 0404183 0404435 0405283 0405348 0406510 0406660 0407382 0407748 0407844 0409421 0409755 0404159 0405637 0405926 0406895 0407005 0405084 0405180 0409839 0405174 0404014 0404171 0404187 0404314 0404526 0405237 0405472 0405522 0405871 0405896 0407001 0408598 0408601 0408761 0408821 0410024 0403801 0404159 0406339 0406752 0404659 0407005 0405884 0405897 0403788 0404014 0404184 0404624 0406610 0408898 0406161 0404937 0408175 0406989 0404001 0404002 0406671 0404133 0404146 0404171 0404172 0404182 0404381 0404435 0404526 0404529 0404530 0404531 0404533 0404608 0404620 0404732 0404846 0404875 0404904 0404979 0405171 0405347 0405348 0405687 0405879 0405910 0406151 0406207 0406286 0406491 0406520 0406560 0406612 0406680 0406892 0407001 0407240 0407580 0407585 0408487 0409058 0409077 0409494 0409554 0409582 0409590 0409592 0409846 0409848 0410323 0406325 0406895 0395514 0404133 0404314 0406829 0395514 0353249 0395514 0404533 0404598 0404734 0404742 0405676 0405887 0406902 0407236 0407462 0407757 0407802 0408372 0408752 0408833 0404479 0404381 0404531 0404573 0405522 0405925 0404617 0405428 0408161 0405428 0405428…
FDA’s list runs to 2,167 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 2,167 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.