Phenobarbital Recall in Canada Due to Oversized Tablets

Health Canada has issued a pms-Phenobarbital recall for 60 milligram tablets of the anxiety and seizure drug distributed by Pharmascience Inc., due to the possibility of that some tablets may be oversized. Receiving too much of the active medication could cause serious physical injury from overdose, such as coma or cardiac arrest.

Consumers in Canada have been urged to return any 60 mg pms-Phenobarbital to their pharmacist for replacement. However, Health Canada indicates that they should not stop taking the medication without first consulting with their doctor, as it could cause symptoms of withdrawal or an increase in seizures.

Phenobarbital is a barbiturate typically used to treat anxiety and sleep disorders that has been on the market since 1912. It is also widely used as an anticonvulsant to control seizures.

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The Canadian recall of Phenobarbital was issued on June 26, 2009, after some oversized tablets were found on the market that contain more Phenobarbital than they were supposed to have. Pharmascience is the distributor of the drug in Canada and indicates that all lots of the 60mg format of the drug are being recalled.

Although no injuries or reactions have been reported to date, a Phenobarbital overdose could cause symptoms like decreased breathing and heart rate, lack of muscle coordination, impaired speech, extreme drowsiness and uncontrolled eye movements. Symptoms generally begin to appear within one to two hours, and could be life-threatening.

There is no indication at this time that the Phenobarbital recall will affect any products distributed in the United States, where it is manufactured by several companies. However, a number of U.S. generic drug makers have experienced manufacturing problems over the past two years involving oversized or undersized pills.

In April 2008, a Digitek recall was issued for all lots of the generic heart drug digoxin manufactured by Actavis Totowa at their New Jersey facility. At least 667 digoxin deaths among users of the drug were reportedly linked to the oversized tablets, according to FDA adverse event reports.

Earlier this year, Caraco Pharmaceutical Laboratories issued a generic digoxin recall for their version of the heart drug, due to manufacturing problems at their Michigan facilities which allowed some pills to contain too much or too little of the active drug. Last week, after the FDA identified continued problems with the drug maker adhering to the current Good Manufacturing Practice requirements, U.S. Marshalls shutdown Caraco’s production facilities and seized their inventory.

Late last year, all generic drugs manufactured by Ethex Corp. were recalled due to manufacturing problems which led to oversized tablets of morphine and other drugs being distributed. A lawsuit was filed last month in Illinois on behalf of three consumers who suffered a morphine overdose allegedly caused by the oversized tablets.

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5 Comments

  • CurtisOctober 7, 2023 at 11:50 am

    Put new one in hopefully to get in some gallery Scott willing. ,,,,,

  • AnneAugust 9, 2009 at 6:37 pm

    Our dog - 6 year old Lab mix - was also on 240 mg phenobarbital per day and did well for two years with her level in the mid range of acceptability until early June 2009. Then she had several serious seizures in a two day period and it was necessary to give her Valium to stop the last one. Then she went swimming in water over her head, had a seizure and nearly drowned. Husband went to rescue her -[Show More]Our dog - 6 year old Lab mix - was also on 240 mg phenobarbital per day and did well for two years with her level in the mid range of acceptability until early June 2009. Then she had several serious seizures in a two day period and it was necessary to give her Valium to stop the last one. Then she went swimming in water over her head, had a seizure and nearly drowned. Husband went to rescue her - water was over his head as well and he is a poor swimmer - by the time he got her on shore she was unconscious and he had to revive her. Then to emergency vet. Very expensive but both are OK. Test the next day showed her phenobarb levels to be on the low end of the range. Has anyone else had this problem.

  • NicoleJuly 13, 2009 at 7:32 pm

    I too have a dog that needs this medication and was shocked to hear of this problem. I was even more upset to find this out just as my dog's perscitption ran out.... thank God I found a refill. Why wasn't I told about it this when it happend. How does something like this happen?? Should we not have strict laws about how all medications are processed?? Not only for our pets but also for the peo[Show More]I too have a dog that needs this medication and was shocked to hear of this problem. I was even more upset to find this out just as my dog's perscitption ran out.... thank God I found a refill. Why wasn't I told about it this when it happend. How does something like this happen?? Should we not have strict laws about how all medications are processed?? Not only for our pets but also for the people who depend on this medication. Why would it take over a month to fix this problem?? This just simply is unexceptable, peoples and peoples pets lives are at stake here. this isn's something that anyone should take lightly.

  • shannonJuly 3, 2009 at 4:21 am

    I would like to know how a company could by accident put a higher dose of a drug into the medication, especially with such a serious drug, phenobarbital, especially because it is a controlled drug and it should be produced with extra care,which all meds should be. My dog takes this medication and she has had side effects which I am monitoring very closly and now she needs more blood tests and live[Show More]I would like to know how a company could by accident put a higher dose of a drug into the medication, especially with such a serious drug, phenobarbital, especially because it is a controlled drug and it should be produced with extra care,which all meds should be. My dog takes this medication and she has had side effects which I am monitoring very closly and now she needs more blood tests and liver tests to see if there is internal damage. Phenobarbital should never have been doubled by accident in dosage, who is making this????? Make with extra care, because my dog is my child!!!

  • ThomasJuly 1, 2009 at 5:30 pm

    Our dog was on 240mg of Phenobarbital a day. A few weeks after starting on the new bottle, he had uncontrollable seizures. Could this have been an effect of the drug? We had too have him put down, he was 3 years old.

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