Precautionary recall of Viridal Duo Powder and Solvent for Injection (EL (17)A/04)
Class 2 Medicines recall: UCB Pharma Limited are voluntarily recalling Viridal Duo Powder and Solvent for Injection (10mcg/ml and 40mcg/ml)
Product information
EL number
EL (17)A/04
MDR number
MDR 72-02/17
Company name
UCB Pharma Limited
Product description
Viridal Duo Powder and Solvent for Injection 10 micrograms/ml PL 00039/0751
Viridal Duo Powder and Solvent for Injection 40 micrograms/ml PL 00039/0753
Batch number/expiry
| Viridal Strength | Batch number | Expiry date | Pack size | Date of first distribution |
|---|---|---|---|---|
| 10 micrograms/ml | 5692601 | 05/2019 | 2 x 1ml | 03/01/2017 |
| 10 micrograms/ml | 5692603 | 05/2019 | 2 x 1ml | 16/02/2017 |
| 40 micrograms/ml | 5678703 | 11/2018 | 2 x 1ml | 13/04/2016 |
| 40 micrograms/ml | 5678705 | 11/2018 | 2 x 1ml | 25/05/2016 |
| 40 micrograms/ml | 5678707 | 11/2018 | 2 x 1ml | 03/08/2016 |
| 40 micrograms/ml | 5678708 | 11/2018 | 2 x 1ml | 08/09/2016 |
| 40 micrograms/ml | 5678709 | 11/2018 | 2 x 1ml | 31/10/2016 |
| 40 micrograms/ml | 5683203 | 03/2019 | 2 x 1ml | 09/12/2016 |
| 40 micrograms/ml | 5683205 | 03/2019 | 2 x 1ml | 29/12/2016 |
| 40 micrograms/ml | 5683208 | 03/2019 | 2 x 1ml | 16/02/2017 |
| 40 micrograms/ml | 5678701 | 11/2018 | 2 x 1ml | 10/05/2016 |
| 40 micrograms/ml | 5678704 | 11/2018 | 2 x 1ml | 02/08/2016 |
| 40 micrograms/ml | 5678706 | 11/2018 | 2 x 1ml | 09/09/2016 |
| 40 micrograms/ml | 5683201 | 03/2019 | 2 x 1ml | 20/10/2016 |
| 40 micrograms/ml | 5683204 | 03/2019 | 2 x 1ml | 03/01/2017 |
| 40 micrograms/ml | 5683207 | 03/2019 | 2 x 1ml | 02/02/2017 |
Brief description of the problem
UCB Pharma Limited is voluntarily recalling the above batches as a precautionary measure due to a possible issue with the integrity of the cap seal which may result in a lack of sterility assurance. The company has received no relevant reports of adverse reactions or product complaints associated with any UK batches to date.
Remaining stock of the listed batches should be quarantined and returned to the original supplier for credit.
Patients are asked to return packs from affected batches to their community pharmacist. Limited replacement stock is available through wholesalers
For stock enquiries, please contact:
UCB Customer Service
Tel: 01753 477770
Freephone: 0800 9233131
For medical information enquiries, please contact:
UCBCares
Tel: 01753 777 100
Email: UCBCares.UK@ucb.com
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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.