Publication #8301

Reference
Drug alert 50/2024
Name
Drug Alert Class 2 Drug Alert 50 2024 – Class 2 medicines recall – action within 48 hours – Bristol Labs – Phenobarbitol Bristol Laboratories 15mg tablets
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Department
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry Medicines Recall
Description
Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles within the tablets. Bristol Laboratories have received one single market complaint relating to a tablet which had been cut in half by the patient prior to administration, revealing the small metallic particle within the tablet core. There have been no other similar reports related to this batch, since the batch was first distributed in December 2022. Whilst preliminary investigations indicate that this contamination is not widespread further investigations are necessary and ongoing. Bristol Laboratories consider it necessary however, to conduct a precautionary recall of the batch whilst such investigations are ongoing. 

Contact Name
Irene Fazakerley
Contact Address
Contact Phone

Created
2024-10-23 09:08:00


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