Class 2 Medicines Recall: Bisacodyl 5mg Gastro-Resistant tablets batch 25074A (MDR 34-04/19)
Chanelle Medical is recalling the above batch because a small number of packs have been found to contain tablets which are stuck together, with mould observed on some tablets. The mould has been identified as a Penicillium species. It is unlikely that affected tablets will have got to patient level as the sticking is noticeable on opening the pack.
MDR Number
MDR 34-04/19
Company name
Chanelle Medical
Product description
| Product | PL Number |
| Bisacodyl 5mg Gastro-Resistant tablets | PL 13931/0005 |
Brief description of the problem
Chanelle Medical is recalling the above batch because a small number of packs have been found to contain tablets which are stuck together, with mould observed on some tablets. The mould has been identified as a Penicillium species. It is unlikely that affected tablets will have got to patient level as the sticking is noticeable on opening the pack.
Advice for healthcare professionals and wholesalers
- Stop supplying the batches listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
- Although only batch 25074A is being recalled, we understand that several batches were manufactured as part of the same campaign. If tablets which are stuck together or show microbial growth are seen for any other batch please do not dispense them. Please notify Chanelle Medical and return to your supplier immediately.
- The correct storage of Bisacodyl 5mg Gastro-Resistant tablets is essential to ensure maintenance of the quality of the product. As indicated on the PIL ‘Do not store above 25oC. Store in the original container. Keep container tightly closed’.
Company contact details for further information
For stock enquiries please contact David Hammond, General Manager, Healthcare Pharma:
Tel: 01233 822 297 Email: rp@healthcarepharma.co.uk
For medical information enquiries please contact
Email: chanelle@medinformation.co.uk
Tel: 0870 1923283
Additional information
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.
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