Serial Or Batch Number And Expiry Date:
| Marketing Authorisation No. | Strength | Batch No. | Expiry date |
| PA891/15/1 | 10mcg | 5692601 | 05/2019 |
| PA891/15/3 | 40mcg | 5678701 | 11/2018 |
| 5678704 | 11/2018 |
| 5678706 | 11/2018 |
| 5683201 | 03/2019 |
| 5683204 | 03/2019 |
| | | 5678709* | 11/2018 |
*Batch distributed as Exempt (Unlicensed) Medicinal Product, only.
These batches were first distributed in Ireland on 21st June 2016
Problem Or Issue:
The Health Products Regulatory Authority wishes to advise that seven batches of Viridal Duo Powder and Solvent for Solution for Injection are being recalled to patient level in Ireland.
Viridal Duo is packaged in a glass cartridge with two chambers, one chamber containing alprostadil in the form of a cake, the other containing sodium chloride solution. These are mixed together to make a solution that is injected into the penis. The reason for the recall is that a small number of units has been observed to have a defective cartridge membrane. The defective membranes have the potential to introduce air and water to the cartridge and, as a result, the sterility of all affected units cannot be assured.
No adverse reaction or complaints have been received to-date, which have been linked to the defect issue.
Actions To Be Taken:
Information for Patients:
- Please check the batch number on the unit(s) currently in your possession.
- If you are in possession of a pack from any of the batches listed above, please return it to your pharmacy
- If you are in possession of pack of Viridal Duo with a batch number not mentioned above, you do not need to return the unit to your pharmacy
- If you have any concerns, please contact your prescriber
Specific Information for Pharmacists
- Please see the pharmacy recall letters inked below for instructions
Pharmacy Recall Letter 23 Feb 2017
Pharmacy Fax-Back Form Letter 23 Feb 2017
Specific Information for Prescribers
Specific Information for Wholesalers: