Generic Phenobarbital and Vicodin Recall Issued After Labeling Mix-Up

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Some bottles of generic Vicodin and Phenobarbital may have the wrong label, which could lead to drug overdoses, unexpected side effects, and patients not getting the medication they require. 

Last week, the FDA announced a Qualitest Pharmaceuticals generic Vicodin and Phenobarbital recall due to the labeling mix-up. The recall came after a bottle of generic Vicodin was found with a Phenobarbital label.

The FDA and Qualitest warn that accidental ingestion of a generic Vicodin (hydrocodone bitartrate and acetaminophen) could lead to serious side effects, including respiratory depression, CNS depression, coma and death. It could also cause liver toxicity when taken with other drugs that include acetaminophen or among patients with liver problems or those who drink more than three alcoholic beverages a day. It could also cause patients who should be taking Phenobarbital to suffer seizures.

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The recall affects three lots of 60-count bottles of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg. The pills have an NDC number of 0603-3888-20. The lot numbers are T150G10B, T120J10E and T023M10A. The recall also affects three lots of 1,000-count bottles of Phenobarbital Tablets, USP 32.4 mg. They have an NDC number of 0603-5166-32 and the lot numbers are T150G10B, T120J10E and T023M10A.

The FDA recommends that consumers using generic Vicodin and Phenobarbital visually verify that they have been taking the correct pills. The generic Vicodin pills affected by the recall are large pink, capsule-shaped and have 3600 debossed into the pill on one side and a V debossed into the pill on the other side. Phenobarbital pills are less than half that size, and are white, round, scored tablets with 5012 debossed on one side and a V debossed on the other.

Qualitest has said that it is notifying all customers who may have received an incorrectly labeled bottle of pills to arrange for their return. There have been no reports of injury or death associated with the mix-up.

The recall comes just a month after 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. Acetaminophen is the main ingredient in Tylenol and used in many cold medicines, but it is also often combined with powerful painkillers.

Vicodin and generics that use the same active ingredients are prescribed more than 100 million times a year in the United States. However, safety issues are a serious concern, as more than 400 people per year die, and 42,000 are hospitalized, from overdoses due to drugs that use acetaminophen.

Tags: Acetaminophen, Liver Injury, Liver Toxicity, Overdose, Phenobarbital, Vicodin

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4 Comments

Gwyn
In October, my 9 yr old golden retriever was prescribed phenobarb for seizures. She was fine with that med until we re-filled the perscription at CVS at the end of December. I noticed in early Jan she was starting to deteriorate.We had to put her down Jan 6th due to uncontrollable seizures. In February I was notified by CVS of the mix-up with the 2 drugs. I was in shock that the pharmacy never picked up the difference in the color of the pills. Not only did the absence of phenobarb cause convulsions but the vicodin is highly toxic in canines. I realize we are not talking about a human life but she was part of our family and we miss her dearly. I am sorry for everyones pain and suffering.
G
I found this website due to googling the word Phenobarbital lawsuit, due to a very upsetting piece of mail I received in the mail after my dear Mother’s passing. I had her mail forwarded to my home address and when I opened a letter from CVS, stating that there might have been a mistake in the labling, and to notify her because she was prescribed both medications. My Mom passed away one day after Christmas, in front of my son and myself, and right before she fell/collapsed she seemed to be very disoriented, she had epilepsy and was only five months in her recovery after having two strokes in two weeks, I’m now wondering if it was because she was taking vicodin instead of her phenobarbital due to she rarely took vicodin, and if so than she wasn’t taking her epilepsy medication at all. Also her autopsy report said she passed away from blunt force trauma, and did have medication in her system. This is all very unclear to me, and my mind is scattered right now. I just need some answers and a little closure in this horrible time.
Tammy
This is very serious I am going through this right now I was prescribed Vicodin for pain after visiting the dentist and prior to that I was taking Wal Mart brand Tylenol/Acet. I wound up in the hospital with abdominal pain so severe I could not walk about 2 days later I was told that my Liver was full of Tylenol and that my gallbladder was full of gallstones but because my liver enzymes were reading so High no surgeon would touch me. I had no idea this could happen to me but it is very real I have developed acute nonautoimmune Hepatitis the Doctor told me it was medication induced and that my liver was not metobolizing any fats and again full of Tylenol I was confused when she first told me this.She bluntly asked if I had been taking large amounts of Tylenol meaning alot of them all at once which I had not only 2 at a time. I now have to stay under the Doctor where my liver is monitored often and every 4-6 weeks my liver enzymes are re-checked it is both painful and EXPENSIVE.
Jerricho
It can be very dangerous because these prescription drugs cause liver damage and can cause death. Mentions Findrxonline abuse of this drug can lead to the addiction and also influences the nervous system.

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