MHRA 发布 Norgine Limited MOVICOL Plain 13.7g 口服溶液粉剂三级召回 EL(26)A/41

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. MOVICOL Plain 13.7g powder for 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 - 40129134

Marketing Authorisation Holder

Norgine Limited

Medicine Details

MOVICOL Plain 13.7g powder for oral solution

PL: 20142/0004

Active Ingredients: macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride

SNOMED code: 11588511000001108

GTIN: 05012748615328

Affected Lot Batch Numbers

Background

Norgine Limited is recalling the above batches of product as a precautionary measure due to some units containing the incorrect amounts of active ingredients.

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.

Advice for Patients:

No further action is required by patients as this recall is being undertaken at retail and wholesaler levels.

The recall is being undertaken out of an abundance of caution, patients in possession of this batch of product may continue to take this medicine.

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 3 Medicines Recall: Norgine Limited, MOVICOL Plain 13.7g powder for oral solution, EL(26)A/41