UCB Pharma Limited is voluntarily recalling their Viridial Duo Powder and Solvent for Injections after concerns that the cap seals are not strong enough. The cap seals are vulnerable to breaking and thus compromising the sterility of the contents.
Viridal Duo Powder and Solvents contain the active ingredient ‘Alprostadil’ and is used for adult males for diagnostic evaluation and treatment of erectile dysfunction. The prescription only injections for diagnostic evaluation purposes are carried out by a trained physician, who will monitor the dose need to produce an erectile response.
For the treatment of erectile dysfunction, this can be administered by a physician or by self-injection.
Whilst patients are not prohibited from self-administering the drug, the medication carries many warnings and strict instructions. Before use, patients or their chosen administer must be trained by a physician on how to safely perform the injection.
As with all medication, physicians and patients must be very careful that the correct medicine, dose and frequency is used. Incorrect medication / doses can cause a number of health issues. Compromised medication must never be used as adverse reactions may occur, and in serious cases, it could be fatal. If there is a broken seal, the medication may react with the air, possibly rendering the medicine not only useless, but also dangerous.
At the time of the recall, there have been no reports of injury or adverse reactions.
The Medicines and Healthcare products Regulatory Agency has since issued a Class 2 Medical Drug Alert, which requires a recall within 48 hours.
The recall concerns the two products:
- Viridal Duo Powder and solvent for Injection 10micrograms/ml PL 00039/0751
- Viridal Duo Powder and Solvent for Injection 40micrograms/ml PL 00039/0753
Around 16 batches have been recalled. Pharmacies and healthcare providers have been urged to check their stock to make sure the recalled products are taken out of use.
If any stock of the listed batches are found, medical staff should quarantine them and return them to the original supplier. If any patients possess any of the listed stock, they should be asked to return the packs to their community pharmacist where some limited replacement stock may be available. Physicians have also been told to instruct patients to strictly monitor the effects, looking out for any adverse reactions or side effects. If the drug’s seal is broken, patients must not use it.
New users are usually given a starting dose between 2.5 or 5 micrograms. It’s likely that patients who possess the 10 or 40 microgram versions Viridal Duo’s will not be strangers to the drug. Whilst this could mean they are used to checking the packaging and are more likely to see an issue, they could also be too familiar with it and may overlook that there is a problem with the drug. Regardless if the seal is broken, UCB Pharma Limited have requested all listed stock to be quarantined and returned.