Excedrin Gas X Buyers May Get Bonus Percocet Painkillers Pills in Product Recall

by editor

How about some Percocet or Vicodin with that Gas-X? Novartis announces a recall of over-the-counter products including Excedrin and Bufferin. Those taking No Doz could garner the opposite effect--in what could be a major mix-up of Endo prescription pills swapped with OTC store remedies.
 
Stupidity associated with pills in wrong hands isn't unheard of but the scenario doesn't typically involve drug manufacturers. It was less than three months ago in October -- after Novartis announced 2,000 job layoffs in the U.S. and Switzerland -- that CEO Joseph Jiminez said: "To strengthen our future, we have accelerated actions to reduce our cost base over the next few years." Apparently that statement is proving accurate. If this week's events serve as any indicator, that plan may already have been instituted well in advance.
 
Novartis makes the stuff that can be bought off store shelves. Endo Pharmaceuticals makes the stuff that isn't. But both are made in the same Lincoln, Nebraska spot. While Novartis makes some of the nation's, and world's, most popular over-the-counter medicines -- including Excedrin, Theraflu, Triaminic, Bufferin, NoDoz and GasX -- Endo makes some of the world's most sought-after prescription meds, including painkillers Percocet and Endocet, Opana and Zydone.
 
Endo Pharmaceuticals makes things like Percocet and (no, the name is not a coincidence) Endocet. Percocet and Endocet are two branded names for what is commonly known by a much simpler one -- Oxycodone, a heavy-duty painkiller medication that contains a bit of acetaminophen. Similarly, Endo's branded painkiller Opana is Oxymorphone. Its fourth popular painkiller, Zydone, is an equivalent of Vicodin -- containing Hydrocodone and acetaminophen. For many, it's the stuff pain relief is made of, in a drug that helps make life livable for sufferers.
 
Oxycodone's a semi-synthetic opoiod created in Germany nearly a hundred years ago, in 1916 -- the drug produced to improve on existing available meds including morphine, codeine and heroin. Before anyone goes out to gobble up existing shelf stock in hopes of getting a 'bonus', those produced lots have been pulled in a recall. Depending upon perception, 'lucky' buyers of over-the-counter stock could have some on hand.
 
So what's the problem that's shut down Novartis and Endo manufacturing? The FDA points to what it sees as a potential manufacturing problem that could mean pills get stuck in machinery, tablets possibly destined for places they aren't supposed to be -- like other product packages.
 
Over 1600 lots of Excedrin, Bufferin, NoDoz and Gas-X are involved in the potential screw-up. It's big enough for the FDA to get involved. And, as most know, that doesn't occur easily. It can take months or years for serious FDA action even with investigation. It took years of 'reworked' moldy applesauce and sick kids before Snokist met FDA action or intervention. And the FDA still isn't involved in an area many argue it should be: Despite arguments that humans are consuming what could be dangerous levels of toxins, with even water overseen by the administration, arsenic in apple juice remains unmonitored by the FDA. Example after example says that when the FDA gets involved, it's more than likely that things are (seriously) serious.
 
It appears problems at the Novartis plant have probably been occurring since about 2009. While Novartis 'voluntarily' shut down the Lincoln plant rather than the FDA forcing any closure, there is a bit more to the story. Awareness of a potential problem isn't exactly brand-new. And failure to address the 'potential' problem doesn't appear to be brand-new either.
 
It seems Novartis was fond of a response that claimed no control: The FDA seems to feel there was no justification for an alleged Novartis response to consumers that alluded to the idea that there were forces "outside of Novartis control". Silly FDA.
 
The administration apparently believes that the entity responsible for manufacturing important things in life, like drugs, should actually have or maintain control over that manufacturing -- rather than blaming a faceless non-entity for things like popping the wrong pills into the wrong bottles. The "outside of Novartis control" claim seems to reflect that either the drug manufacturer's learned a lot from insurance companies, and their infamous "act of God", or a "Wizard of Oz" redux has hit the Lincoln facility: Those pills must have been hit by a tornado, swirled and swirled, then hurled -- into random bottles before being capped, routed for transport and slated for destination of OTC store shelves.
 
The FDA report says Novartis doesn't maintain enough personnel at its Lincoln, Nebraska, plant or enough employees responsible for reviewing consumer complaints. The administration feels that those who do scan those complaints aren't doing such a great job at it, citing the idea of those people being poorly trained. And the administration seems to feel it was supposed to have been kept in the loop. It claims a frequent lack of notification to the FDA within a required timeframe, failure by Novartis to follow up with those consumers whom had filed complaints, failure to inform top brass about any sway or swing from quality control procedures -- and failure to escalate even the worst or most critical complaints upward in the corporation.
 
The Novartis plant in Nebraska had officially been cited about half a year ago by the FDA, when FDA inspectors pointed to a dozen quality control problems. The accusation is that Novartis officials failed on a couple of fronts: The FDA says Novartis failed to properly investigate over 150 complaints (166 to be exact) of mixed-up pills discovered, by consumers noting "foreign tablets", in Novartis bottles for the past two to three years -- since 2009. The FDA inspectors also believe that none (as in not one) of 223 customer complaints sent to the Novartis manufacturing plant in 2011 were adequately reviewed by the drug manufacturer. Shocking.
 
2010 saw 587 complaints pour in to Novartis over its Lincoln plant. 165, the FDA says, were not properly or adequately addressed by the drug manufacturer. That's over one-quarter, or about 28-percent, that weren't properly handled, according to the FDA. The administration apparently sees no joke in what Novartis would prefer dubbed as a "potential". The FDA seems to have a different view, that lies more along the lines of 'problem', making the following statement to the drug manufacturer: "Your [Novartis] quality assurance unit has consistently failed to review critical complaints for drug products manufactured and packaged at your [Lincoln, NE] facility." The voluntary plant closure is probably due to what would have been a not-so-voluntary one otherwise.
 
While four Novartis products have been officially recalled, there's a fifth that's been involved in the fiasco: While the antacid branded as Prevacid hasn't been officially recalled or yanked, at least one report claims a consumer discovered unnamed tablets in a package of the product purchased.
 
Novartis and Endo share the facility that pumps out pills. Perhaps Endo should've been paying some closer attention to Novartis 'practices'. The pharmaceutical company is certainly focused on potential problems now, since the drug-maker is taking a forced plunge along with Novartis. It may all sound funny -- and Excedrin or Gas-X buyers may consider a stray tablet a bonus that seriously relieved a headache or bloating problem -- but the craziness in overseeing production holds serious repercussions for patients who do actually need medicines to manage severe pain.
 
The Novartis problem means Endo Pharmaceuticals' manufacturing has also been closed for now. With Novartis voluntarily closing its Lincoln doors before the holidays, as of December 19, Endo prescription painkillers like Percocet face shortage. How bad that shortage of drugs becomes depends on how fast Novartis can sort out its issues and work with the FDA.
 
Endo Pharmaceuticals claims no knowledge of any swapped pill screw-up reaching its patients taking Percocet, Endocet, Opana and Zydone -- or of any mix-up causing injury. Even if it's true, the interesting part is that patients would have almost no way of being aware of the error -- other than knowing they'd had one hell of a day in suffering from excruciating pain.
 
Endo says the only Novartis product that shares a manufacturing line with the pharmaceutical company's painkillers is Gas-X. If that's the case, someone may have gotten quite some gas relief with no easy explanation as to why -- until now.
 
Endo's statement is a cause for pause, since it makes Novartis' actions a bit odd: If only one OTC product had any potential for being mixed with pain tablets, it would seem awfully strange that three additional Novartis products are involved in an expensive recall. Novartis is yanking a total of four over-the-counter products, not one -- and those additional producgts include some of the nation's most major OTC ones including Excedrin and NoDoz tablets with expiration dates of December 20, 2014 in addition to a portion of Bufferin and Gas-X packages expiring December 20, 2013 or prior.
 
The FDA and Endo Pharmaceuticals is apparently advising consumers to use the logical, "which of these things does not belong here" method. Patients are instructed to examine pills to ensure tablets match up in shape and color, size and marking. If the pills don't look alike, patients are to return those meds to the issuing pharmacist. Don't worry: Endo won't tell.
 
Kept more hush-hush is the idea that the shutdown's will likely affect more than consumers needing relief from headaches and gas -- or students needing that caffeine boost for all-nighters. It may be Excedrin, Bufferin, GasX and NoDoz brands that are directly involved in the recall but the byproduct of the closure means those hit by other common ailments could also find themselves in dire straits. Excedrin is no longer being shipped for now, and there's no slated date for when new arrivals of "the headache medicine" will be destined for shelves.
 
And while the Novartis plant is in the midst of closure, other important stuff could also be available in lesser supply -- unfortunate for those in the midst of flu or cold seasons, shipments of Theraflu and Triaminic no longer shipping. Shipments of Maalox, Lamisil and Benefiber are also ceased until further notice.
 
On the upside, Novartis may be able to straighten out its act before flea season: The drug manufacturer isn't shipping veterinary drugs like Sentinel to treat fleas in dogs and cats and has also stopped shipping its medicine branded as Interceptor. But fortunately for pet owners, Novartis has a few months to sort out manufacturing issues before those fleas strike.
 

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