BEVACIZUMAB & DXM, SDPF
Medicine recall D-1464-2012. 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
- 2350 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?
BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16”) 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16”) 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2”) 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2”) 25MG/20MG/ML INJECTABLE 0.07 ML, 1.33 ML, 1.4 ML, 1.47 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2”) 25MG/40MG/ML INJECTABLE 0.35 ML, 0.7 ML, 1.05 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.63 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 30G, 1/2”) 25MG/20MG/ML INJECTABLE 1.8 ML, 2.7 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 31G, 5/16”) 25MG/20MG/ML INJECTABLE 0.18 ML, 0.27 ML, 0.45 ML, 1.08 ML, 13.5 ML,2.25 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2”) 25MG/16MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 1 ML, 1.2 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML, 7.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2”) 25MG/40MG/ML INJECTABLE 4 ML, 6 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16”) 25MG/16MG/ML INJECTABLE 2 ML, 2.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16”) 25MG/20MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 0.6 ML, 0.7 ML, 0.8 ML, 1 ML, 1.5 ML, 55.1 ML, 57.5 ML, 57.6 ML, 58 ML, 7.5 ML; BEVACIZUMAB & DXM, STSL (0.1ML SYRINGE, 30G, 1/2”) 25MG/16MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB & TMC, SDPF - (0.075ML SYRINGE, 30G 1/2”) 25MG/40MG/ML INJECTABLE 0.075 ML, 0.15 ML, 0.225 ML, 0.375 ML, 0.75 ML, 1.125 ML, 1.5 ML; BEVACIZUMAB & TMC, SDPF (0.075ML SYRINGE, 30G, 1/2”) 25MG/80MG/ML INJECTABLE 0.45 ML, 0.75 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, 30G, 1/2”) 25MG/40MG/ML INJECTABLE 0.3 ML, 0.5 ML, 1 ML, 2 ML, 2.5 ML, 3 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.5 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.075ML SYRINGE, 30G, 1/2”) 25MG/80MG/ML INJE 0.375 ML, 0.525 ML, 0.75 ML, 1.125 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.15ML SYRINGE, 30G, 1/2”) 25MG/40MG/ML INJEC 0.6 ML, 0.75 ML, 0.9 ML, 1.05 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2”) 25MG/20MG/ML INJECT 0.2 ML, 0.4 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2”) 25MG/40MG/ML INJECT 0.6 ML, 1 ML; BEVACIZUMAB IN ARTIFICIAL TEARS 0.5% (5MG/ML) OPHTHALMIC 5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 27G, 1/2”) 25MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 30G, 1/2”) 25MG/ML INJECTABLE 0 MLS, 0.05 ML, 0.1 ML, 0.15 ML, 0.2 ML, 0.2 MLS, 0.25 ML, 0.25 MLS, 0.3 ML, 0.3 MLS, 0.35 ML, 0.36 ML, 0.4 ML, 0.45 ML, 0.5 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 1 ML, 1.2 ML, 1.25 ML, 1.5 ML,1.5 MLS, 1.75 ML, 1.8 ML, 10 ML, 15 ML, 2 ML, 2.25 ML, 2.5 ML, 2.5 MLS, 2.55 ML, 2.6 ML, 3 ML, 3.1 ML, 3.5 ML, 3.6 ML, 3.65 ML, 3.7 ML, 3.75 ML, 3.96 MLS, 4 ML, 4.5 ML, 5 ML, 5 MLS, 7 ML, 7.2 ML, 7.2 MLS, 7.25 ML, 7.3 MLS, 7.3 VIAL, 7.4 MLS, 7.5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16”) 25MG/ML INJECTABLE 0.1 ML, 0.15 ML, 0.2 ML, 0.25 ML, 0.3 ML, 0.35 ML, 0.4 ML, 0.5 ML, 0.55 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 0.85 ML, 0.9 ML, 1 ML, 1.1 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.75 ML, 10 ML, 12.25 ML, 12.5 ML, 13.5 ML, 15 ML, 17.5 ML, 2 ML, 2.25 ML, 2.5 ML, 2.6 ML, 3 ML, 3.5 ML, 3.75 ML, 4 ML, 4.5 ML, 5 ML, 5.05 ML, 6 ML, 6.25 ML, 6.35 ML, 7.5 ML, 8.75 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 30G, 1/2”) 25MG/ML INJECTABLE 1.2 ML, 2.88 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 31G, 5/16”) 25MG/ML INJECTABLE 1.5 ML, 1.8 ML, 2.4 ML, 3 ML, 3.6 ML, 4.8 ML, 6 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 30G, 1/2”) 25MG/ML INJECTABLE 1.75 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 31G, 5/16”) 25MG/ML INJECTABLE 0.14 ML, 0.21 ML, 1.75 ML, 3.5 ML, 4.2 ML, 5.6 ML, 7 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, 30G, 1/2”) 25MG/ML INJECTABLE 0.08 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.08 ML, 0.16 ML, 0.24 ML, 0.32 ML, 0.48 ML, 16 ML, 8 ML; BEVACIZUMAB, SDPF - (0.1
2350 units, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Rx #’s: 0359160 0405079 0364389 0364389 0361241 0377683 0377683 0377683 0377683 0401661 0401661 0401661 0390308 0359300 0404762 0382630 0407996 0361441 0407996 0387326 0398781 0356812 0398781 0356812 0375792 0403341 0375792 0399708 0387144…
Every code shown here, 2,000 characters
Rx #’s: 0359160 0405079 0364389 0364389 0361241 0377683 0377683 0377683 0377683 0401661 0401661 0401661 0390308 0359300 0404762 0382630 0407996 0361441 0407996 0387326 0398781 0356812 0398781 0356812 0375792 0403341 0375792 0399708 0387144 0399708 0387144 0375792 0353919 0375792 0389701 0357461 0387144 0389701 0397437 0352503 0357461 0377580 0377580 0386958 0386958 0367201 0371279 0371279 0367201 0384322 0371279 0384322 0367201 0384322 0384322 0375486 0375486 0375486 0375486 0390996 0381779 0361290 0391677 0403321 0361290 0403321 0397396 0393484 0401740 0390929 0393759 0384195 0388799 0388805 0393759 0388805 0393484 0387836 0387836 0398119 0350119 0359128 0400639 0353914 0394457 0353914 0382205 0353914 0394457 0382205 0393293 0393299 0393300 0399578 0399598 0390926 0393485 0388801 0393485 0388806 0368969 0368969 0390918 0390918 0390918 0392167 0357998 0402352 0393760 0393760 0356752 0401186 0369338 0380167 0367010 0369225 0384207 0385361 0387698 0394363 0395273 0396614 0398024 0398662 0399938 0403502 0408817 0359129 0367010 0367401 0370758 0370759 0370763 0370767 0370768 0370770 0370778 0370779 0370783 0370785 0374018 0374024 0374028 0374036 0379772 0379773 0379774 0387698 0388817 0396342 0407944 0407945 0407946 0408269 0408741 0408742 0408817 0370141 0370142 0371173 0371773 0373627 0376439 0378889 0378890 0378892 0378894 0378897 0378898 0378899 0382662 0382666 0382667 0382669 0382670 0382674 0382919 0383307 0383314 0383346 0385937 0388305 0396302 0399567 0401360 0407944 0407945 0407946 0407948 0407951 0407955 0408233 0408237 0408242 0408248 0408250 0408251 0408259 0408262 0408264 0408265 0408271 0408272 0408274 0408280 0408281 0408284 0408672 0408673 0408674 0408675 0408676 0408677 0408678 0408679 0408680 0408681 0408682 0408683 0408684 0408685 0409171 0409173 0409188 0409191 0409205 0409207 0409825 0409826 0409827 0409828 0409829 0409830 0409831 0352123 0359738 0376439 0384103 0385937 0388817 0401360 0401986 0367896 0355412 0359738 0360220 0371173 0372305 0372673…
FDA’s list runs to 10,375 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 10,375 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
-
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.