MHRA 发布二级药品召回，SyriMed 巴氯芬 10mg/5ml 口服溶液两批次被召回（EL(26)A/06）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Baclofen 10mg/5ml Oral Solution
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-38317957

Marketing Authorisation Holder

Syri Limited, T/A SyriMed

Medicine Details

Baclofen 10mg/5ml Oral Solution

PL: 39307/0090

Active ingredient: baclofen

SNOMED code: 38757711000001104

GTIN: 5055935104700

Affected Lot Batch Numbers

Background

Syri Limited, T/A SyriMed is recalling the above batches of product as a precautionary measure due to crystallisation observed over time in the oral solution. Testing results show that the assay of the filtered oral solution does not comply with the licensed specification of the product and there is a potential risk of sub-therapeutic dosing. The recall is at pharmacy and wholesaler level.

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.

Advice for Patients:

No further action is required by patients as this is a pharmacy and wholesaler level recall. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Do not stop taking baclofen suddenly without medical advice as you may get withdrawal side effects.

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 on https://yellowcard.mhra.gov.uk/

Additional information:

For medical information enquiries please use the following options:

Email: [email protected], or telephone +44 (0) 330 1359 422.

For stock control enquiries please email [email protected]

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: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(26)A/06