Recall alert: Blood pressure medication recalled after oxycodone pill found on production line
This sounds like some sort of sabotage by a disgruntled employee. Sort of reminds me of situation abt 40 yrs ago https://www.history.com/news/extra-strength-tylenol-poisonings-1982, where someone took some Tylenol Extra Strength from a store and tampered capsules of Extra-Strength Tylenol. Someone had opened the capsules and replaced the pain-relieving medicine with deadly doses of potassium cyanide. They then proceeded to put the bottles of Tylenol Extra Strength back on the retail shelf they took them from, killing seven people.
While Oxycodone 5 mg taken by someone who it was not prescribed to, probably may not cause any personal harm … unless the person is severely allergic to Oxycodone and/or opioids in general. However, the finding of any Oxycodone 5 mg in a few bottles of betaxolol, will cost the pharma KVK-Tech, Inc a untold amount of $$ in doing a recall to one or more lot numbers of the medication.
KVK-Tech, Inc. is voluntarily recalling a single lot of 10-milligram betaxolol tablets “as a precautionary measure” after a single oxycodone hydrochloride tablet was found on the same production line, according to the U.S. Food and Drug Administration.
Betaxolol is a drug used to combat high blood pressure. Oxycodone hydrochloride is a drug used for pain relief and is a narcotic that’s a “popular drug of abuse,” per the U.S. Drug Enforcement Administration.
The 10-mg betaxolol pills are white, round and film-coated, with one side displaying a “K” and the number “13.” The pills were packaged in white plastic bottles, each filled with 100 tablets, and distributed to wholesalers and retailers nationwide. Bottles in the affected lot — Batch Number: 17853A — have an expiration date of June 2027.
According to the FDA, the company found a single, five-milligram oxycodone hydrochloride tablet on the packaging line during line clearance — the process of making sure equipment is free of materials — after the recalled betaxolol batch was packaged.
“The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration,” the FDA release warns. “Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid.”
“Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk,” the release reads.
The FDA notes that betaxolol and oxycodone hydrochloride tablets look similar. KVK has not received any reports of foreign tablets in bottles of betaxolol tablets.
According to the FDA release, if you received pills from the recalled lot, stop using them and immediately return them to KVK-Tech. The company will reimburse you for the cost of purchasing the medication, the release states.
You can contact KVK-Tech at 215-579-1842, Ext: 6002, or by email at customerservice@kvktech.com.
Filed under: General Problems
KVK is one of the six banned Pharmaceutical Manufacturers by The Cleveland Clinic. Following are all the banned Pharmaceutical Manufacturers by The Cleveland Clinic. Their products are banned across the board and for good reasons obviously:
Apotex
Caraco
Dr. Reddy
Glenmark
KVK
Sun
I’ve been at it with the FDA for a number of years now as they keep denying that anything is wrong with generic drugs. Read Bottle Of Lies by Katherine Eban for more info.
I’ve been sounding this alarm for years, as have others and seemingly no one cares. How many must be harmed or killed before this stops?
KVK tech has had many issues with their manufacturing process.
I experienced severe side effects from their generic 10mg oxycodone.
My physician insisted it was due to the % of active ingredient.
The article above is alarming and confirms my beliefs that mistakes were made in the process.
I’ve had horrid reactions to the same med you referred to from Alvogen, Camber and Endo Pharmaceuticals. Par Pharmaceuticals is Endo’s generic company, BTW. I CANNOT take them. I took each of the above mentioned brands for months and then *POW* the next month’s refill nearly put me in the ER. I reported all this to the FDA through Medwatch but they couldn’t care less. I’ve tried to get the pills analyzed to no avail. The FDA is simply not interested nor is anyone else. I’ve spoken with people all over the world about this but no help has been forthcoming. I also have a $10,000,000.00 claim filed against Endo and Par through their bankruptcy filing. My claim has been accepted and I’ve been issued a claim number. I don’t expect to see one thin dime from this but I DO hope that my story will be told publicly for ALL to hear (and probably not care about). I have ALL the physical evidence that could possibly be needed. Irene, your physician is full of BS. It has nothing to do with the % of active ingredient and everything to do with corruption and incompetence at the Pharmaceutical manufacturers, the FDA and perhaps more private and governmental agencies. Tell your story non-ceasingly to anyone that will listen. This is of the utmost importance!
Does this come by any other name? Generic?
According to a database on my Iphone the brand name Kerlone was produced by Sanofi-Aventis and the database indicates that the brand name has been DISCONTINUED in the USA. The recall is specific for a generic pharma product – a single lot of 10-milligram betaxolol tablets. I suspect that any pharmacy that has dispensed this med would be reaching out to their pts
Seeing as how 5mg is the typical starting dosage for an opioid naive individual, it really does seem like the FDA is being totally disingenuous with their statement. If they had mentioned potential for allergic reaction, that would’ve been understandable, but citing respiratory depression, as well potential for decreased heart and lung function just sounds like a bunch of hysteria laden crap to me. Unless, of course, the patient is in the habit of taking several blood pressure pills at once. But if that’s the case, the risk of inadvertently taking a single 5mg Oxycodone seems like it would be a moot point. I’m going to go out on a limb and guess this facility will either incur a HEFTY fine or they’ll be shuttered entirely, possibly both, over this SNAFU. There is apparently no bottom to their anti-opioid barrel or one would think they’d have hit it by now.