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THE IRISH HEALTH Products Regulatory Authority (HPRA) has today confirmed that an epilepsy drug is being recalled “as a precautionary measure”.
The company ViroPharma SPRL is recalling several specific batches of Buccolam Oromucosal Solution, which is used to treat convulsive seizures in children and adolescents.
There was an issue identified in relation to manufacturing controls at one site and there was a “theoretical risk of cross-contamination”, the HPRA said in a statement today.
There is no evidence of any actual cross-contamination having occurred with the Buccolam products, and the potential contaminant has not been detected in any batch of Buccolam during product testing to date. Nevertheless, these batches of Buccolam are being recalled to pharmacy level as a precautionary measure.
The specific products being recalled are:
As a precautionary measure, pharmacists are being advised to quarantine any units of the Buccolam batches being recalled and to return them to their wholesaler. Replacement batches – manufactured at a different site – will be provided.
“No safety or quality issues have been identified in any of the batches released onto the market,” commented Kevin O’Donnell, Market Compliance Manager at the HPRA. “The recall only applies to packs at pharmacy level, and the risk presented by this issue is considered to be very low. Patients do not have to return packs to their pharmacy and can continue taking their medicine.”
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Best wishes to him. Clinical depression is a tough battle.
@Carm(Orange Vampire): he’s lucky to have the best help available, the rest of us are literally on the edge of ????????
Should never have put himself forward for election, clearly unfit to do the job.
@John Fahy: fitter than that g0bshite Dr. Oz.
@Jen Mc: Oz was a terrible candidate but it was known long before the election that Fetterman was have serious cognitive isues. The man has trouble deciphering what people say in a normal one on one conversation, he never had any hope of winging it as a Senator.
This is just another example of the degradation of American politics where people don’t vote for ideas or character, they simply vote for their chosen team. Put a ‘D’ on a turnip and the average Democrat will vote fo it. (same for the other side)
@Will: all that tells me is that people understandably despised Dr. Oz enough to vote for Fetterman and that the Dems didn’t have anyone more fit for purpose to put forward. Or were they looking for the sympathy vote? Either way, I’d rather Fetterman than Oz.
Get Well Soon, John, unfortunately the Repubs will be gloating over this.
Oz was a respected cardiologist. Fetterman can’t string two sentences together. Should’ve been a no brainer.
@Samantha Samantha: Oz was endorsed by Trump, that was the end of his hopes.
@Samantha Samantha: You must have missed the bit where Oz defrauded his TV audience by selling and making millions out of meds that didn’t work or Oprah’s criticism of him. Did you read the bit on Fetterman’s success in fighting crime and the fact that he has his own opinions. As for the cardiology bit, he certainly didn’t show John Fetterman much sympathy after his stroke, which doesn’t reflect well on him.
have your say