Novartis hopes to gradually restart production at its Lincoln, Nebraska manufacturing plant as early as May, and resume shipping some products at mid-year. But a return to full production will probably not happen until 2013.
Production will restart on a line-by-line basis, according to David Epstein, Division Head of Novartis Pharmaceuticals, who offered a status update during the Novartis 1st Quarter 2012 Earnings Conference Call earlier today (April 24th)
“[W]e are in the middle of quality remediation activities at Lincoln,” Epstein said, “and we are making good progress. We had a meeting with the FDA recently, and shared with them our startup plan for the plant. We will begin production in May and we will resume shipments mid year.”
Epstein indicated that the “ramp up” would be slower than expected. “We’ll have a relatively limited portfolio in the back half of the year. So we have signed up some third-party manufacturers for some key products,” he explained. Neither Epstein nor any other participant in the conference call specified the order in which Excedrin and other products manufactured at that plant would reappear. Nor was there any indication as to which products would be farmed out to third-party manufacturers.
Novartis suspended production at its Lincoln facility on January 8, 2012 and recalled more than 125 million bottles of Excedrin and other OTC medications after a FDA inspection revealed flagrant and long-standing deficiencies in the company’s quality assurance and consumer complaint procedures. The shutdown of the Lincoln plant also has affected availability of a number of veterinary products, including Interceptor, a popular medication for preventing heartworm in dogs and cats.
I asked FDA for a description of the steps usually undertaken in a situation such as this one. After making the usual disclaimer that “FDA does not comment on an ongoing investigation,” Shelly Burgess of FDA’s Office of Public Affairs offered the following explanation:
“FDA investigators conduct routine inspections at drug manufacturing facilities to determine, among other things, compliance with the current good manufacturing practice regulations. When the investigator finds significant deviations from those minimum standards, he or she lists the deviations on a document called a form FDA 483, or the “483,” and issues that to the manufacturer at the conclusion of the inspection. By providing this notice, the Agency gives a manufacturer the opportunity to take voluntary and prompt corrective action. The manufacturer may submit a written response to the Agency explaining how it has corrected the violations or plans to do so, or explain why it disagrees with any of the listed observations. In most cases, manufacturers comply voluntarily but in some instances FDA sends the manufacturer a warning letter or an untitled letter. In addition, where appropriate, FDA may pursue enforcement action such as seizure and injunction.”
“The timeline can vary considerably depending on the extent of the corrective actions that are required for the firm to achieve compliance and demonstrate sufficient controls over manufacturing to produce acceptable quality drugs. Some deficiencies can be corrected within hours or days of notification such as when re-training an employee or fixing a piece of equipment. Other corrective actions may take days or months, such as qualifying a complicated manufacturing operation or validating a new test method.”
It’s not surprising that the restart in Lincoln will be slower than Novartis had originally hoped, or that the company is being vague regarding which products will receive priority when production at the facility resumes. No one wants a repeat of the problems that led to the recalls and shutdown.
Nevertheless, the delay will result in additional headaches for consumers, pharmacists, doctors, and veterinarians as the product shortages continue.
eFoodAlert 
Have anyone found an alternative to exceed tine cause I haven’t 😦
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Excedrine…. Dang autocorrect
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My pharmacist said the generics are identical in everyway.
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Has anyone thought that Excedrin works so well it may have pissed off some other pharm company, I mean it must be cutting into their (Prescript) profits if you can buy something that works this well OTC? (I like to read medical mystery thrillers LOL)
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Funny how Bayer came up with the same formula as excedrine. Looks like our government is getting their way. Imagine that? I don’t believe that our current president understands what a Migrane is. Hopefully he will udnerstand after November and the PEOPLE finally raise their voices…..
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I watch tv consistently. I have yet to see anything about a recall of excedrin.!!!!!!!!!! It continues to amaze me how incompent our news programs have become, all networks included. The only thing they want to report is their skrewed opionion of our lying president of the united states.!!!!!!!!!!!!!!!!!!!!!!!
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The government doesn’t bother with info like that. You are right, they are focused on one thing. Excedrin is losing millions of dollars from the loss of sales. They REALLY had things mixed up at the plant. When Excedrin comes back, expect generous coupons to get the customers back. They messed up royal!
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I just read that the CEO of the company that manufactures Excedrin, says it will be back on shelves in October. Fingers crossed!
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I read on here that someone was going to start taking Bayer.have horrible back & body pain. My Daughter told Me to get Excedrin Back& Body. When I couldn’t find it I asked the Pharmacist who in turn told Me it was pulled from shelves. She recommended Bayer Back & Body. I can’t believe it, but it really does take My pain away. I’m also Sorry for all of You migrane sufferers who need Excedrine back. I heard it is coming back in October. Don’t know how true that is though. Donna
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It sad that so many are suffering and production to get it back on the shelves seems so far away. It is the only product that helps mine and my husbands headaches; also our other acts and pains. Please work faster to get it back to us faithful consumers.
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Living in a rural area I wondered if we would be the last to see Excedrin return. There is a Walmart, CVS, & Rite Aid nearby, though. Excedrin is the only over-the-counter medicine that gets rid of my husband’s & my headaches. Please get it back on the shelves soon!!
Peggy Sollenberger
Woodstock, VA 22664
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Come on people…Please hurry! We need our Excedrine. I have had bad headaches almost everyday. I cant wait for them to get this product back out. Yes, all the others, Walmart, CVS, Walgreens DONT compare! I’am a school bus driver and it will not be long and schools IN! And so are the migraines. When will it come back? This is August 2012 people!!! I will become a squirrel and stockpile it like it were NUTS! Please hurry, hurry for ALL of us who suffer everyday get it back out in our stores.
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If you type in excedrine migraine you will see it costs upward of 100 dollars on the net becuase people need it and can’t get it. People are desperate to get it back because the second you feel a headache coming on and you take one or two it goes away and doesn’t come back. Love love love that product and beg beg beg them to hurry up and bring it back.
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I suffer from daily headaches and pain in my back and neck. Since exedrine was taken off the shelf I suffer daily. Walgreens and CVS pain relief brands do not work. If I keep taking these brands 4x a day my liver will soon shut down. Bring me back my exedrine!
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like so many EXCEDRIN is the only pill that provides the relieve I get/need from my headaches and back pain.. if any of them ever had a blinding headache or any back pain that brings you to tears well perhaps they would put a SERIOUS MOVE ON GETTING IT BACK ON TH SHELVES!! What is with all the horse hockeying around. GET THE STUFF back out there.. Please.. !!!
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Why couldn’t they just fix issues as they came up instead of lining there pockets? Missing r excedrin back an body!!!!! It was all that helped! Think we will officially switch to Bayer.
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Except Bayer Back & Body has caffiene which I don’t like to take at night so I am still waiting for the Excedrine Back & Body. I have not found a true exact substitute for it yet.
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Miss Excedrin too. Use the generics too but they don’t work nearly as well. I take daily meds to prevent migraines and Imitrex when I get a terrible one. Realize I “NEED” the Excedrin to keep any “quality of life.”
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From what I understand Novartis allowed that factory to fall in such disrepair and shambles that the FDA was close to shutting them down anyway so they really had to rebuild the thing. Shows what greed can sometimes cost businesses…and it’s clients!
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I am 51 years old and started getting migraines at age five during this time
There was a drug that my parents could get with a prescription to make a long story short the drug is no longer available. I was using Tylenol that
Was a joke when lucky to still have kidneys. had a friend that told about Excedrin. I had been using Excedrin for about 20 years now. I am now
Forced to buy the generic want to be EXCEDRIN the Walgreens and Wal-Mart brand is a joke. don’t kid yourself it doesn’t work and it not the exact same thing as EXCEDRIN they call it a generic for reasons the chemicals
Compound are lower grade then what is in EXCEDRIN..
It is like comparing tide laundry soap to armor hammer not the same.
Work as fast as you can to bring back EXCEDRIN!!!!!!!!!!!!
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The migraine geltabs work quickly and without adding stomach upset.It made you feel better to know that you had Excedrin in supply when you desperately needed it; not to sound like a an addict but migraine sufferers understand the need.
Years ago there was a OTC pill for migraines call Actron. It was a tiny little white pill and it did a super job but suddenly it was withdrawn from the market. I called about this and was told it was recalled and some consumers had adverse reactions to the pill. This was before internet information was available. I’l never know about that but I had taken the pills for some time ??
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Years ago when I worked in a pharmacy while going to college, the pharmacist told me generics have the same ingredients as the name brand but they may not be compounded in the same way. I have never found a generic that works as well as Excedrin, so for now I just take two aspirin and drink a Coke (not Pepsi, Coke).
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Take one extra strength Tylenol, one full strength aspirin and either a caffeine pill or strong cup of coffe. Voila!
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that is my exact solution. until excedrin comes back, i will continue to do the exact thing TRAVELLERSU is doing. and unless excedrin gets their act together soon, all of us migraine sufferers may have hit upon something and say “excedrin, you took too long, we no longer need you “. this is ridiculous !!!!!!
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I’ve also taken Excedrin for years and get killer migraines that I also have prescription meds for. But I have found generics to work just as well – Walgreens and WalMart (and no doubt other stores) have generic versions with the IDENTICAL ingredients. They are chemically identical to Excedrin, and I think a lot of people’s belief that ONLY the brand name works is partly psychological. No less real, but chemicals are chemicals.
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I agree! I have been using Walgreens generic Excederin since the recall and can’t tell the difference in effectiveness. I may stay with them after Excedrin is back…they are about 1/2 the price!
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I disagree 100% – it is not the “generic drug” that is the problem with these “want-to-be” Excedrin replacements, IT IS THE FILLERS USED to make the pill. I have had horrible reactions to every one except Excedrin. I too, think the brands from Walgreens, Walmart & even CVS are poor subtitutions. NEED EXCEDRIN!!!!
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Yes,,I Agree,,Those Pills That Walmart And Walgree And Cvs Have ,,They Can-not Compare To EXCEDRINE,,With Which They Think,,,No Way,,Can Those Other Pills ,,Compare With —EXCEDRINE! Please Hurry Back With The EXCEDRINE,,That;s The Only Pill That HELPS My Artheritis!!!!!! Please Hurry Back With The EXCEDRINE!!! Thanks For Your Unstanding!!!
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Cheer up, just stopped in my local gas station – cum food mart, and low and behold, they had those little two packs in the Excedrin drawer – manufactured by another factory, but packed for delivery to the store in the Excedrin boxes we all recognize. The pill bears the same numbers the original Excedrin had on them, but no E. The store manager told me that it was delivered to them in Excedrin packaging, and low and behold, I am without a back ache for the first time in several months. Chin up, hopefully they will keep them coming.
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Thank you so much Carol for the update. I was curios what state do you live in? I’m in Wisconsin. Thanks
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curious
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How do you know about the numbers? And what do you mean, “no E?”
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Please tell Us,,Were We Can Find Thease Pills ,…Quote Excedrine,,Without The—LETTER —E! We Sure Could Use Them For My ,,,Artheritis Condition Which Is ,,,Sooooooooooooo Painful!!! Help Now,,If You Will!!! Jeannette Ps,Thanks So Much!
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My pharmacist told me the new Bayer Migraine is identical to Excedrin. Give it a try.
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I have been mourning the loss of Excedrin as well and will again buy it from Sam’s for the huge quantity….AFTER I buy a small bottle to make sure we are getting the SAME product. I can’t believe it’s been this long.
I haven’t been able to find the information to substantiate the comment but someone told me that there was an additional ingredient in Excedrin that was not approved…Heck if I know except that I swear by it and now am without. I will say, the closest substitute is BC Powder…but taking it will make a man out of you. 😉 open the packet, pour the powder under your tongue and then drink to swallow, preferable a Coca cola. I’ve tried water, ginger ale, beer, etc but Coke is the best. It’s about the best option around until Excedrin comes back.
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I also have found generics to be useless. As I read these comments, it really has made me wonder if there was something in Excedrin that we are not aware of. I have a bottle of generic migraine formula here and it has the same items in the same doses listed as my empty Excedrin bottle, including the caffeine. They don’t provide anywhere near the relief that the Excedrin does. What don’t we know? Just why does Excedrin work so well?
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I find that the store brands of Excedrin work just as well.
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Makes me wonder why it has taken this long? I’m a long-time headache suffer. But something is not right in Denmark no product should take this long to be put back on the market. And tell me why the generics I bought still give me no relief? What is in Excedrin that I don’t know about umm!
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What makes excedrin work and not tylenol is excedrin has caffeine in it. It’s the only pain medicine that works for me.
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I NEED EXCEDRIN BACK ON THE SHELVES!!! I too suffer from Migraines and it is the ONLY non-prescription product that works! Please let us know where and when we can buy Excedrin Migraine as soon as possible!
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PLEASEEEEEE PLEASEEE, PLEASE PUT EXCEDRIN BACK ON THE MARKET ASAP ! NOTHING ELSE WORKS, AND I’VE BEEN GOING STORE TO STORE IN HOPES OF FINDING IT, AND WHEN I DO I BUY PACKS OF THEM FROM THE LOCAL CORNER STORE ! I HAVE INTENSE HEADACHES AND EXCEDRIN PRODUCTS ARE THE ONLY THING THAT WORKS FOR ME.
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I sooo agree with all here. Even my migraine medication is not helpful. I need my Excedrin back and I definitely will be stockpiling on this as I use to anyway and stopped. Now I am suffering as I am now getting no relief from my migraines. NOTHING else works.
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I ECHO ALL THE OTHER COMMENTS AND AD IVE TAKEN EXCEDRIN FOR 50 YEARS! MY HEADACHES ARE DOOZIES. WHEN I TOLD MY HUSBAND ONLY EXCEDRIN WORKED FOR ME, HE KIDDED ME WITH 2 ASPRIN ONE NIGHT BEFORE AN OFFICERS CLUB PARTY . HE ASKED ME HOW MY HEADACHE WAS DURING THE EVENING AND I TOLD HIM ID HAD NO RELIEF WHICH HAD NEVER OCCURED SINCE I STARTE3D TO TAKE EXCEDRIN, THEN HE TOLD ME HE,D TRICKED ME TO PROVE ANY ASPRINE WAS ENOUGH! I,D TAKEN TWO BAYER! I HAD TO LEAVE THE PARTY AND GO HOME TO GET MY EXCEDRINE. IT HAS NEVER FAILED ME ONCE! I MUST HAVE IT! MY HEADACHES ARE GOING WITHOUT RELIEF!!!!! YOU CANT SELL SOMETHING FOR ALL THIS TIME AND THEN JUST SWIPE IT INDEFINATLY……ITS JUST NOT FAIR TO YOUR FAITHFUL CUSTOMERS. PLEASE BE SO KIND AS TO SUPPLY IT AT ONCE.. AND, SEND PLENTY WE;LL BE STOCKPILING.
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I dont think there has ever been a recall that took this long to resupply from.
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I need my Excedrin back. Generics are not working. I should have stock piled. I didn;t realize they would be out this long with no plans to come back until God knows when.
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I agree with Laurie nothing else works sad when you need something and it has been taken away
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I agree with all the above…when oh when are we getting excederin back on the shelves. This is undue punishment for keeping your business going for as long as it did. I invested more money in excederin, gas x and other products that it should be a crime to just take someone’s medicine away. That causes more health problems than anything. Please get them back at the stores.
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Are there any updates for the excedrin it is the only one that does work. Looking forward to it’s return
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Just read the ingredients on the bottle and cross shop a generic version. I get mine from Walmart, and the cost is $0.02/pill. Same ingredients, much less money.
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I have used Excedrin DAILY for years (with doctor approval)! When, when can we expect it back of the shelves? Nothing else works. There must be something you can do for us headache suffers…this is most unfair as we are using other products in the meantime and not getting good results. Please respong to our urgent pleas. Thank you, Bobbie
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Please get Excedrin Migraine back on the market. I honestly can find NOTHING to replace Excedrin Migraine for my headaches. Must spend days in bed! PLEASE hurry!!!
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By the way, do you have any Excedrin that was recalled and deemed safe that we could purchase directly?
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Excedrin is a superior product. It really works for me and I am anxous to have it back on sale.
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What would you recommend taking for a migraine? Nothing is seeming to work and my head is killing me. Oh, please help
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I miss Excedtin I’m going to be I e of the first buying it up and having a stock pile, my migrains need u, hopefully buy u soon!
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I too have taken Excedrin for years with wonderful results. I need it back. The generics do not work for me and I have multiple problems that I take the medication for.
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Hi I Just Want To SAYYYYYYYYYYYYYY Pleaseeeeeeeeeeee Bringggggggg Backkkkkk The ,,,EXCEDRINE!!!!!!!!! Nothing Else Helps My ,,,Artheritis,,,,BUT EXCEDRINE! I Am In Pain Every Day,,Please I Am waiting And Looking For The EXCEDRINE To Come Back,,Real Soon!!!!
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