Vicks Sinex Nasal Spray Recall: Risk of Infection from B. Cepacia Bacteria

Published: November 20th, 2009

About 120,000 bottles of Vicks Sinex Vapo Spray are being recalled due to the potential risk of infection from bacterial contamination.

The Vicks Sinex nasal spray recall was announced on Thursday after Procter & Gamble discovered the presence of B. cepacia bacteria in some bottles of nasal spray at the company’s production plant in Gross Gerau, Germany. There have been no reported illnesses connected to the contamination.

Bukholderia cepacia (B. cepacia) is bacteria often found in soil and water that is often resistant to commonly used antibiotics. According to the Centers for Disease Control and Prevention (CDC), the bacteria carry little risk for healthy people. However, it does pose a threat to people with weakened immune systems or chronic lung diseases, particularly cystic fibrosis. Individuals with these health problems appear to be more susceptible to B. cepacia respiratory infections.

B. cepacia is often linked to medicine contamination. In 2004, another nasal spray, Major Twice-A-Day 12 Hour Nasal Spray by Propharma, was also recalled due to B. cepacia contamination.

The contaminated batch of Vicks Sinex nasal spray was divided into three lots and distributed to the United States, United Kingdom and Germany. All three lots are being recalled. In the U.S., the recall affects lot # 9239028831 of Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml, Nasal Spray. In the U.K., lot # 9224028832 of Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml was recalled. The German batch was lot # 9224028833 Wick Sinex Schnupfenspray Dosiersystem, 15 ml.

Proctor & Gamble and the FDA recommend that anyone who has this nasal spray stop use of it immediately and contact Procter & Gamble for a refund or replacement coupon. Any adverse effects should be reported to FDA’s MedWatch adverse events reporting program.

Nostrilla Nasal Decongestant Recall: Bacterial Contamination (10/21/2011)
Vicks VapoSpray and Sinex Nasal Spray Recall Issued for Decongestants (6/28/2010)
Zicam Loss of Smell Lawsuit Filed Over Recalled Nasal Spray Cold Remedy (1/13/2010)
Swine Flu Nasal Spray Recall Issued Due to Problems with Vaccine Strength (12/23/2009)
Zicam Nasal Spray Lawsuit Alleges Loss of Smell After One Use (7/30/2009)

There Are 29 Comments So Far • (Add Your Comments)

Comment by peter on 20 November 2009:
Stated with a chest infection October 4th went to Doctor was precribed antibiotics no effect used vicks sinex,the condition got worse had a second course of antibiotics then more test and x-rays the inection/bacteria was found to be resistent to both the prescribed antibitics so recomended to take TRIMETHOPRIM .Gradualy getting better but still have chest/lung problem .have also stoped using sinex about 5/6 days ago.
Comment by james on 20 November 2009:
another product made oversea’s cheap labor no quality control american co makes money we get sick
Comment by ANITA on 20 November 2009:
I HAVE ALWAYS USED VICKS VAPOSPRAY, I HAVE 2 BOTTLES IN MY
PURSE NOW, IT IS THE ONLY ONE THAT CLEARS MY HEAD. I HATE TO THINK THAT I COULD NOT USE THIS ANYMORE.
Comment by Meghan on 20 November 2009:
Should i be worried,,, am i going to die…. i have been sick
Comment by Joyce on 21 November 2009:
I have used Vicks products including the inhaler for relief of stuffy noses.No other product Ive tried gives me the relief that Vicks does. I understand if there is a temporary problem.But I sure hope it gets back on its feet and back to the product I “ve always looked to for relief . Im 58 years old and a 14 yr. Liver Transplant and Vicks products have never hurt me,so get back on the shelves Vicks.
Comment by Patti on 22 November 2009:
I have been using Vick’s Vapospray for years.I just finished a bottle of Vicks vapospray 4 hour and have a new 12 hour decongestant.It is not the ultra fine mist,but i had that before.I have had nasal problems for at least a year .I have had allergy tests and they were negative -How can you assure me that my nasal problems are not causd by your product ? since I buy whatever Vicks Sinex vapospray the store is carrying at the time
Comment by Kimberly on 24 November 2009:
Ironically enough, I e-mailed vicks just last month10/17 about any adverse health affects vicks may cause…They e-mailed me back saying”none of our products are addictive!” I was at my Drs. office for a respriratory infection Thursday of last week. I hope the Vicks sinus spray isn’t the cause, since this “virus” is resistant to a lot of anti-biotics!
Comment by Jason on 1 December 2009:
I have been using VapoSpray for 2 years. I have been sick with a sinus cold and bronchtis for 3 weeks. I am just know getting better. I wonder if that was form the spray? Has anyone had similar problems?
Comment by Ruth on 16 December 2009:
I had used Vicks Sinex Vapospray for little over a month when I heard about the recall. I have been sick for 2 weeks with infection. The infection settled in my inner ear and I am so dizzy I can’t walk very well. Dr. says it is my inner ear. Never been so sick in my 61 years. Been to emergency room twice, four other dr. visits also. Am now on steroids trying to help the dizziness. Has anyone else had any of these problems. I have always been very healthy and am so frustrated right here at Christmas can’t even drive to do my shopping. Could this nasal spray have caused my problem?
Comment by stacy on 23 December 2009:
I have been using this product for years and my ENT told me using this vicks sinex had destroyed the lining in my nose. I had surgery 4 weeks ago today and am still fighting infection. I called P&G about the recalll and though the bottles I have do not have the same batch # as their recall they would not confirm that they test each batch. They are wanting me to send them all the bottles I have and want my medical records. P&G would not even offer to refund me on all the bottles I will never use let alone even care that I just had surgery. Leviquin is the only antibiotic I am responding to and that is a awful drug in itself.
Comment by marc on 23 January 2010:
Hi Folks …I use this stuff everyday.I use two bottles a week i think its to much but i need it for my nose it works great …
Comment by cruztacio on 1 March 2010:
well ever since I foud out about this vick sinex and its effectiveness i have bough it but now i cant find it when will it be back on the market because I have not have no other product that thoes to my congestion what vick does, i have had this problem ever since i was 13 years and now it seem a lot worse. please sinex come back to the market please please………..
Comment by elia on 19 March 2010:
wow, the commenters on this page have a cumulative IQ of about 45. unbelievable.
Comment by Russell on 19 March 2010:
Have only just found out today why Synex was removed from the shelves. I have used Synex for about 12 years and at least once per day normally at bed time to prevent my sinus blocking off causing a bad nights sleep. Since using Synex I have gone through many winters without cold or flu which means no time off work. Had to revert to Drixine which makes me feel more than uneasy so hurry up Vicks, I look forward to you restocking my pharmacy with Synex again ASAP.
Comment by Steve on 8 July 2010:
I have used this spray since i was a child and went to 5 or 6 stores and finally a walmart store told me it was on recall after checking alot of stores. Its the only thing that clears my nose others do not work.
Hope to see it in the stores again.
Comment by Saticon on 10 July 2010:
I use this all the time– and the 12 hour kind just doesn’t do it for mne, it has to be the 4 hour- the active ingredient is different between the two- 4 & 12 I hadn’t heard of the recall but I couldn’t find 4 hour anyway, today I went in a CVS some distance freom my home and thought I struck gold- they had 12 bottles of the 4 hour I took all 12 to the register to buy then the clerk said “funny, it comes up “can’t sell product” she asked a super who told us of the recall….. I hope hey get new botgtles out quick I’d even use thge recalled ones ,the risk seems acceptable to me
does anybody know why they discontimnued the 4 hour in th mist pump? That was even better than he spray bottle.
Comment by Madelyn on 12 July 2010:
I have used Vick’s Nasal spray for years. It is the only thing that works. I got so sick I could barely move, blinding headaches…all I could do is lie on the couch. I kept using the spray since I couldn’t breathe. However, I noticed that my nasal passages were very swollen and sore. They continued to get worse. When I tried to blow my nose, blood would come out. This went on for almost two weeks. Then, when I went to buy more spray, I was told about the recall. No more info was available at the time. I tried another brand, which of course didn’t work as well, but I needed something. I did start to slowly improve. the swelling went down so I could breathe some better. It is still not right, but it is better.
Comment by Joan on 20 August 2010:
I have used This nose spray for years. It is the only one I h ave ever found that will open my nose. I have tried many brands. Where can I buy this spray on line???
Comment by mel on 21 August 2010:
hi, i\\\’m 60 years old and i can\\\’t remember when i didn\\\’t use vicks 4 hour nasal spray,it\\\’s absolutely the best product for nasal conjestion.
please try to get your quality control problems fixed,if you actually have any which i doubt.
by the way i would use the 12 hour but it actually makes the problem worse for me. i know that sounds silly but its a difference in the formulation. GET TO WORK:PLEASE GET 4 HOUR BACK
Comment by M. on 12 September 2010:
This product is the only one that works for me. Surely, by now, the problem is fixed, and manufacture can continue. At present, it is not available in Sydney, Australia. BRING IT BACK ASAP !
Comment by Anne on 22 September 2010:
Vicks 4 hour with the active ingredient, phenylephrine is the only product I’ve found that clears my sinuses and alleviates the pressure headaches. Since I couldn’t find it, I purchased Vicks vapoinhaler, with
active ingredient levmetamfetamine. This doesn’t even unplug my nose let alone reach my clogged sinuses!
Please get the 4 hour w/ phenylephrine back on the shelves soon!
Comment by Jennifer on 7 November 2010:
I live in Mexico and i went to buy some Vicks nasal spray and nowhere to be found. I even asked someone to go to the states to find some and nothing. Well little did I know it was recalled GEEZE now what do I do. I need it back too PLEASE!!!
Comment by Aaron on 29 December 2010:
Aha! So *now* I know why! None of the pharmacists here in Sydney Australia would tell me why.
—
*Please* make a big effort to bring it back as the others I’ve been forced to try are *really* bad. I’m having to use “Dimetapp 12hr” which has a awful rebound effect (nose blocks even more tightly as soon as it wears off). Before that, I was recommended–and used–a generic no-name brand that the pharmacist said had the same “active ingredient” as Vicks Sinex. But it would not clear my nose for the duration of a good night’s sleep.
Comment by karrie on 16 January 2011:
I too have been using Vicks and it is the only thing that gives me relief as well. I went to several other locations (mostly CVS/Walgreens, etc.) – asked the pharmacists and none of them stated anything about a recall. Please figure out what is wrong – fix it and get it back on the shelves. What you have out there now is no better than Afrin! The menthol that is in it totally clears up whatever blockage might exist at the time.
Comment by Kenr55 on 24 January 2011:
Don’t you folks read the warnings and indications that come with Vick’s Sinus spray – it’s not for long time use. My ENT only recommends using it for three or four days tops – that’s it. If you use it beyond that point, your body gets used to it and then addicted to it – yes – you’ll have what they call a “Rebound Effect”. Without a dose, your sinuses will swell up and become inflamed and clogged – and the only way out, in the beginning, is to use the spray.
These sprays – all of them, are really highly addictive. And the only way to get off of them is to use some sort of Cortisone like spray – something like Nasonex -that’s what works for me.
So please read the labels on any over the counter medicine you take – if you don’t you’re really putting your life and your health into somebody else’s hands.
So be wise and read – that’s the only way you’ll really know what you’re taking and what it will do to your body and your health.
Comment by Lexie on 10 March 2011:
im scared. im 11 years old and i used Vicks VapoSpray. wich is a nasel sray. well i accadently tiped my head back and sprayed it up my nose. and of course it went through my throught. i could tast it… it was gross. i started freaking out. i ran to my dads room and i was scared i told him what happend. then he laghed and said its supposed to go down your throught. then he gave me a bottle of water to get the tast out. it did help but in was still in my throught. so i went back in my room and blowed my nose to get the spray out. then i got it out. but i still had it in my system. i looked at the label and it said…. IF ACCEDENTAL INGESTION PLEASE CALL A PIOSON CONTROL CENTER RIGHT AWAY. thats exaclely what i did.. well i DID NOT call a pioson center at all. but i did ingest it. im still worried. am i going to die?
Comment by Diane on 4 June 2011:
ive been on sinex 4 hour for about 17 years,its the only one that works,the new and improved 12 hour sinex sucks..please bring the 4 hour back on shelves,luckily i overstocked,and still have 1 bottle left forget the recall you aint getting mine back,hurry up im getting low
Comment by Randy on 10 November 2011:
Ive been using Sinex for years and Its the only product period that gives me relief. Now Im a mess. Im missing work and unable to drive sometimes. I hate being a mouth breather. My wife dose not even want to kiss me anymore. Alot of people are suffering. Please put the recalled sinex back on the market so I can breath better and keep my marriage happy and so I can keep my job without further hinderance by taking so many sick days off
Comment by Silent Cal on 10 December 2011:
The new 12 hour stuff doesn’t work for me, either! I’m pretty miserable. I used the 4 hour formula for years only at night with a Breathe Rite strip and slept like a baby. The phenylephrine plus whatever base was used in the four hour product was cooling and worked immediately. The oxymetazoline formula in the 12-hour version isn’t cooling, and makes me feel dehydrated. I wake up with a dry mouth and a stuffy nose. Please bring back the 4 hour. There’s no need to completely abandon this product. Re-issue it with the same active ingredient and that menthol sensation, but put it in an orange box and it’ll be easy to identify as safe.