MHRA 对 Accord-UK 盐酸乐卡地平 10mg 薄膜衣片批号 M2510877 发布 2 类召回（EL(26)A/45）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Lercanidipine Hydrochloride 10mg Film-Coated Tablets
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Patients
8. Additional information
9. Download document
10. Annex 1

DMRC reference number

DMRC - 41285957

Marketing Authorisation Holder

Accord-UK Ltd

Medicine Details

Lercanidipine Hydrochloride 10mg Film-Coated Tablets

PL: 00142/1154

Active Ingredient: lercanidipine hydrochloride

SNOMED code: 16607111000001105

GTIN: 05055565768242

Affected Lot Batch Numbers

Background

Accord-UK Ltd is recalling one batch of Lercanidipine Hydrochloride 10mg Tablets due to a packaging mix-up involving the incorrect strength. One complaint has been received to date, in which a sealed carton of Lercanidipine Hydrochloride 10mg Tablets 28 (Batch No. M2510877) was found to contain one blister strip of the correct tablets, and one blister strip of Lercanidipine Hydrochloride 20mg Tablets (Batch No. M2510831).

This recall is being conducted at the pharmacy and wholesaler level as Accord-UK Limited has shown that the likelihood of the mix up, and the subsequent risk to patients, is low.

If a patient prescribed lercanidipine 10 mg were to inadvertently receive 20 mg daily for approximately two weeks, the anticipated risk would be an exaggerated pharmacological effect; particularly reduction in blood pressure with associated symptoms such as dizziness, headache, flushing, palpitations or symptomatic hypotension. However, 20 mg remains within the authorised therapeutic dose range for routine use of this product. The tablets have distinct colours and the occurrence of the defect is currently anticipated to be very low.

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.

This recall is at the pharmacy and wholesaler level and not directed to patient level as 20 mg remains within the authorised therapeutic dose range for routine use of this product. The tablets have distinct colours and the occurrence of the defect is currently anticipated to be very low. However, should a patient present a pack with the incorrect medicine, pharmacy teams should exercise their professional judgement to supply the correct medication.

Advice for Patients:

Accord has received a single report of a carton of Accord-UK Ltd Lercanidipine Hydrochloride 10mg Tablets containing a blister strip of Lercanidipine Hydrochloride 20mg Tablets and are being recalled as a precautionary measure. 20 mg remains within the authorised therapeutic dose range for routine use of this product. The tablets have distinct colours and the occurrence of the defect is currently anticipated to be very low.

If you were prescribed Lercanidipine Hydrochloride 10mg Tablets, and received an Accord pack with batch number M2510877, please carefully check the blister strips inside (the batch number and expiry date information can be found on outer carton, see the images in Annex 1).

If the carton contains blister strips that are labelled as Lercanidipine Hydrochloride 10mg Tablets, you do not need to take further action and may continue to take the tablets.

If the carton contains a blister strip that is labelled as Lercanidipine Hydrochloride 20mg Tablets, do not take the medicine, contact your pharmacy.

If you believe you have taken the Lercanidipine 20mg Tablets and are currently experiencing any side effects such as dizziness, headache, flushing or palpitations then please seek immediate medical advice. Please take the leaflet that came with your medicine and any remaining tablets with you to your pharmacy or GP practice.

If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals involved in your treatment.

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 Accord-UK Medical Information Department medinfo@accord-healthcare.com, or telephone 01271 385257.

For stock control enquiries please email Accord-UK Customer Services Team customerservices@accord-healthcare.com, or telephone 0800 373573.

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

DMRC@mhra.gov.uk

Download document

Class 2 Medicines Recall: Accord-UK Ltd, Lercanidipine Hydrochloride 10mg Film-Coated Tablets, EL(26)A/45

Annex 1

Lercanidipine Hydrochloride 10mg Tablets – Carton

Lercanidipine Hydrochloride 10mg Tablets – showing Batch details

Lercanidipine Hydrochloride 10mg Tablets – Correct blister of 14 tablets BN M2510877

Lercanidipine Hydrochloride 20mg Tablets – Incorrect blister of 14 tablets BN M2510831

Differences in appearance between Lercanidipine Hydrochloride 10mg Tablets and Lercanidipine Hydrochloride 20mg Tablets.