Community Pharmacy England (CPE) yesterday (October 23) said that one batch of Phenobarbital 15mg tablets, which are used to control seizures, had been recalled by manufacturer Bristol Laboratories Ltd.
This was done “as a precautionary measure due to the potential of contamination of small metallic particles within the tablets”, CPE said.
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Bristol Laboratories received “one single market complaint” about the epilepsy drug after a patient cut a tablet in half “prior to administration” and discovered a “small metallic particle within the tablet core”, it added.
There have been “no other similar reports” related to this batch, which was first distributed in December 2022, according to CPE.
It said that preliminary investigations have indicated that the contamination is “not widespread” but stressed that further investigations are “necessary and ongoing.”
Stop supplying “immediately”
The alert advised pharmacies to stop supplying the affected batch “immediately”, quarantine “all remaining stock” and return it to their supplier.
But it stressed that patients should continue to take medication from this batch “as prescribed”.
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It warned that a sudden break in the administration of phenobarbital could cause a patient’s seizures “to start again” or happen more frequently and “last longer than before”.
The affected batch, which has a pack size of 28 tablets, is NU22001 and expires in October 2025, it said.
Last month, the medicines watchdog urged healthcare professionals to stop supplying anaemia drug Oxbryta “immediately” after new data revealed “an unfavourable imbalance” of “fatal events” and “acute painful crises” in patients on the drug.