Class 2 Medicines Recall: Norgine Pharmaceuticals Limited, Pedmarqsi 80 mg/mL solution for infusion, EL(26)A/42

Pedmarqsi 80 mg/mL solution for infusion

Norgine Pharmaceuticals Limited is recalling the batches listed in the table due to risk of particulate matter being present in the product identified during routine stability investigations. No adverse reactions related to this issue have been reported by users.

Norgine Pharmaceuticals Limited has confirmed that the issue is currently limited to the two batches in this recall. However, investigations concerning all other batches are ongoing.

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

Other batches of this product remain available for continued use. Healthcare professionals are reminded of the Patient Information Leaflet instruction to inspect visually the content of the vial(s) for particulate matter and discoloration prior to administration.

Inline filters may be used with this product.

This is a Pharmacy and Wholesaler level recall, therefore no further action is required by patients. This product is normally administered by healthcare professionals in a hospital setting.

Norgine Pharmaceuticals Limited have not received any reports of adverse reactions related to the issue.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

For all medical information enquiries and information on this product, please email [email protected], or telephone +44 (0) 1895 826606.

For stock control enquiries please email [email protected], or telephone +44 (0) 1895 826600.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.