Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall
Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord), Aptil Pharma Limited (now Torrent) and Dexcel Pharma Ltd due to contamination.
Brief description of the problem
All batches of the above products are being recalled at a European level due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
Product details
| Product Name | Marketing Authorisation Holder | PL number |
|---|---|---|
| VALSARTAN 40MG CAPSULES, HARD | DEXCEL PHARMA LIMITED | PL 14017/0192 |
| VALSARTAN 80MG CAPSULES, HARD | DEXCEL PHARMA LIMITED | PL 14017/0193 |
| VALSARTAN 160MG CAPSULES, HARD | DEXCEL PHARMA LIMITED | PL 14017/0194 |
| VALSARTAN 40MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0109 |
| VALSARTAN 80MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0110 |
| VALSARTAN 160MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0111 |
| VALSARTAN 320MG FILM-COATED TABLETS | ACTAVIS GROUP PTC EHF | PL 30306/0405 |
Healthcare professionals and wholesalers
Stop dispensing the products listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. An investigation into other potentially impacted products is currently being undertaken and further updates will be provided as the investigation progresses.
Company contacts for further 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, hospitals and community pharmacists for information.