MHRA Class 3 Medicines Recall: Sildenafil 10mg/ml Oral Suspension (Rosemont Pharmaceuticals Ltd)

Drug alert number: EL(23)A/11

Date issued: 21 March 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Sildenafil 10mg/ml Oral Suspension (Rosemont Pharmaceuticals Ltd) – PL 00427/0258

Active Pharmaceutical Ingredients: Sildenafil (as Citrate)

Brief description of the problem

Rosemont Pharmaceuticals Limited has informed the MHRA that the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) in the batch listed above is too wide to fit the neck of the medicine bottle.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

There is no risk to product quality as a result of this issue, and the affected batch is being recalled as a precautionary measure. Rosemont Pharmaceuticals Limited has confirmed that no other batches will be released with the incorrect PIBA and that the majority of the impacted packs have been distributed to hospitals (secondary care) where the doses will be administered under the supervision of a healthcare professional. A small number of packs have been dispensed by primary care teams, therefore specific advice is included below for patients (and healthcare professionals) who have been supplied with these packs. 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.

Full drug alert can be viewed here.

Further Information

For more information, medical information queries or replacement PIBA enquiries, please contact: pharmacovigilance@rosemontpharma.com. For stock control queries, please contact: customerservices@rosemontpharma.com.