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Rosemont sildenafil 10mg/ml oral suspension recall

One affected batch

March 21st 2023

Tagged: MHRA alert

By MHRA

Rosemont Pharmaceuticals Limited is recalling one batch of sildenafil 10mg/ml oral suspension due to a problem with the bottle adaptor.

The affected batch is

Batch numberExpiry datePack sizeFirst distributed
SLD22002April 2025122mlJune 2022

In the affected batch, the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) is too wide to fit the neck of the medicine bottle.

Advice for healthcare professionals

Healthcare professionals are asked to quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Healthcare professionals should note that the PIBA is an aid to dispensing and the oral suspension can be administered accurately using the syringe without the PIBA.

Patients who are self-dosing should be advised to discard the PIBA and use the 2ml oral syringe supplied with the medication to obtain the required dose directly from the medicine bottle following the instructions below:

  • Keeping the bottle upright, insert the 2ml oral syringe supplied into the bottle ensuring the tip of the syringe goes below the level of the liquid.
  • Fill the syringe with a small amount of suspension by pulling the piston up whilst maintaining the tip of the syringe below the level of the liquid, then push the piston down in order to remove any possible bubble.
  • Pull the piston upward to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.
  • Remove the syringe from the bottle.
  • Close the bottle with the plastic screw cap.
  • Empty the contents of the syringe into your mouth.
  • After dosing, wash the syringe with water only.

For more information, medical information queries or replacement PIBA enquiries, please contact: [email protected]. For stock control queries, please contact: [email protected].