MHRA Class 2 Medicines Recall: Pedmarqsi 80 mg/mL solution for infusion (Norgine Pharmaceuticals Limited)
MHRA Class 2 Medicines Recall: Pedmarqsi 80 mg/mL solution for infusion (Norgine Pharmaceuticals Limited)
Drug alert number: EL(26)A/42
Date issued: 12 October 2026
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.
DMRC reference number: DMRC-41054154
Company name: Norgine Pharmaceuticals Limited
Medicine Details
Pedmarqsi 80 mg/mL solution for infusion (PL: 20011/0078)
Active Ingredient: sodium thiosulfate
SNOMED code: 44928411000001103
GTIN: 5012748616745
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| 458273 | 12/2026 | 1 | 09/01/2025 |
| 475287 | 12/2026 | 1 | 25/09/2025 |
Background
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.
Advice for Healthcare Professionals
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.
View the alert here.
Advice for Healthcare Professionals to Provide to Patients
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.
Additional information
For all medical information enquiries and information on this product, please email MedInfo@norgine.com, or telephone +44 (0) 1895 826606.
For stock control enquiries please email UKIsupport@norgine.com, or telephone +44 (0) 1895 826600.
