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Federal drug regulators are warning that some bottles of Qualitest generic Vicodin and Fioricet may have had their labels swapped due to a manufacturing problem, meaning that some patients could be taking the wrong drugs.
A Qualitest generic drug recall was announced on June 27 after at least one bottle of generic Fioricet was found with a generic Vicodin label.
The FDA and Qualitest warn that unintentional Fioricet consumption by people with an allergy to butalbital, one of its active ingredients, could result in a hypersensitivity reaction. They also warn that those who were already on Vicodin could experience increased pain and withdrawal symptoms. There were no reports of anyone having suffered adverse events due to the labeling mix-up.
Philips DreamStation, CPAP and BiPAP machines sold in recent years may pose a risk of cancer, lung damage and other injuries.
Fioricet is a combination drug that includes butalbital, acetaminophen and caffeine. Butalbital is a barbiturate and acetaminophen is the active ingredient in Tylenol. It is approved for the treatment of tension headaches and muscle contraction headaches.
Vicodin (hydrocodone and acetaminophen) is a powerful opioid painkiller approved to relieve moderate to severe pain. It and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States.
The recall affects four lots of 500-count bottles of Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, by Qualitest. The lot numbers are C0390909A, C0400909A, C0410909A, and C0590909B, and the bottles have NDC 0603-2544-28. It also affects four lots of 1,000-count bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, by Qualitest, with lot numbers C0390909A, C0400909A, C0410909A, and C0590909B, and NDC 0603-3882-32. The lots were distributed between November 13, 2009 and April 9, 2010.
The FDA recommends that any consumers who received a prescription from either affected medications check to visually ensure they have the right pills. The generic Fioricet pills are white, have 2544 stamped into them on one side and a “V” on the other and are 11 mm in diameter. The generic Vicodin pills are 16.5 mm in length and are white with green specks, capsule shaped with 3594 stamped on one side, as well as a “V” on the other side.
This is the second time this year Qualitest has had to recall generic Vicodin and a barbiturate due to a label mix-up. On February 5, 2011, three lots of generic Vicodin and Phenobarbital were recalled after a bottle of Vicodin was found with a Phenobarbital label.
In January, the FDA announced that it was placing limits on the amount of acetaminophen in Vicodin, Percocet and similar painkillers. The agency is also requiring stronger label warnings regarding the risks of liver injury.
2 Comments
I have been taking Fioricet for years, since 1977 to be exact. This medication has helped in some cases but mostly has caused many financial, mental trauma, suicide attempts, seizures and many other problems in this now 35 years of use. Other medications do not provide the relieve from my cluster tension headaches like Fioricet w/o Codeine does but the other side effects far out way the benefit an[Show More]I have been taking Fioricet for years, since 1977 to be exact. This medication has helped in some cases but mostly has caused many financial, mental trauma, suicide attempts, seizures and many other problems in this now 35 years of use. Other medications do not provide the relieve from my cluster tension headaches like Fioricet w/o Codeine does but the other side effects far out way the benefit and therefore I have been on a long path of recovery from detoxing from this medication.
Had stroke in 2001. I have written medication documentation list that was given to me after I was release from this hospital. St Francis Medical Center, Tacoma Washington. Also on that medicatio list is Simvastin which I had taken for more than 5 years..
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The Court has indicated that a three groups of Combat Arms earplug lawsuits, each including 500 claims, will be prepared for trial in the coming months.
Parties involved in litigation over the cancer risks of the heartburn drug Zantac will take part in a Zantac Science Day today and tomorrow in federal court.
A former Paraquat applicator says he was told the herbicide was toxic, but not that it could cause Parkinson’s disease in a recently filed lawsuit.
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