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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Viridal Duo Powder and Solvent for Solution for Injection 10 micrograms/ml & 40 micrograms/ml (EL (17)A 04)

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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