CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2…
Medicine recall D-1488-2012. 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
- 86 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?
CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 300 ML, 32 ML, 4 ML, 5 ML, 6 ML, 60 ML, 90 ML; CYANOCOBALAMIN **1000MCG/ML INJECTABLE 1000MCG/ML INJECTABLE 30 ML; CYANOCOBALAMIN*** (25X10ML VIAL) 1000MCG/ML INJECTABLE 10 ML, 20 MLS, 40 ML; CYANOCOBALMIN ***(VIT B-12) 25X1ML 1000MCG/ML INJECTABLE 50 MLS (24 DIFFERENT PRODUCTS)
86 units, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Rx #’s: 0387434 0387442 0373259 0379220 0379925 0381812 0382155 0389481 0391043 0391912 0392598 0393303 0397302 0368903 0385563 0377621 0389560 0376591 0387169 0375580 0388039 0381499 0387434 0387442 0368903 0398369 0385601 0381154 0382450…
Every code shown here, 535 characters
Rx #’s: 0387434 0387442 0373259 0379220 0379925 0381812 0382155 0389481 0391043 0391912 0392598 0393303 0397302 0368903 0385563 0377621 0389560 0376591 0387169 0375580 0388039 0381499 0387434 0387442 0368903 0398369 0385601 0381154 0382450 0395591 0399380 0400168 0401501 0375406 0388039 0370251 0379203 0380414 0373568 0373668 0379036 0376722 0380943 0381499 0384292 0388741 0395917 0373742 0387702 0389521 0373742 0401945 0409583 0404840 0407920 0407921 0407922 0407923 0407925 0407926 0407928 0407931 0407933 0407935 0403019 0406664
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.”
- 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.