MHRA 发布二级药品召回：Norgine Pharmaceuticals Limited 的 Pedmarqsi 80 mg/mL 输液用溶液（EL(26)A/42）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Pedmarqsi 80 mg/mL solution for infusion
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Patients
8. Additional information
9. Download document

DMRC reference number

DMRC - 41054154

Marketing Authorisation Holder

Norgine Pharmaceuticals Limited

Medicine Details

Pedmarqsi 80 mg/mL solution for infusion

PLGB: 20011/0078

Active Ingredient: sodium thiosulfate

SNOMED code: 44928411000001103

GTIN: 5012748616745

Affected Lot Batch Numbers

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.

Advice for 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 [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.

Yours faithfully

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

[email protected]

Download document

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