MHRA发布Accord Healthcare异丙托溴铵500微克/2毫升雾化溶液Class 3召回（批次UK25B06）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution
4. Affected Lot Batch Numbers
5. Background
6. Advice for Healthcare Professionals
7. Advice for Healthcare Professionals to Provide to Patients
8. Additional information
9. Download document

DMRC reference number

DMRC - 37371169

Marketing Authorisation Holder

Accord Healthcare Limited.

Medicine Details

Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution

PL: 20075/0692

Active Ingredient: Ipratropium bromide

SNOMED code: 11006411000001107

GTIN: 05055565739587

Affected Lot Batch Numbers

Background

Accord Healthcare Ltd is recalling the above batch after a foil pouch was found to contain ampoules with incorrect labels intended for the Korean market. The incorrectly labelled ampoules are the same product and contain the same active ingredient but have Korean language labels and different batch details.

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 Healthcare Professionals to Provide to Patients:

No action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level.

Patients who have taken the mislabelled ampoules will have received the correct medication as it is the same product but with labels intended for the Korean market.

If you have concerns about this, contact your dispensing pharmacist in the first instance.

Patients who experience adverse reactions or have any questions about their 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 [email protected], or telephone 01271 385257.

For stock control enquiries please email Accord-UK Customer Services Team [email protected], 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

[email protected]

Download document

Class 3 Medicines Recall: Accord Healthcare Ltd, Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution, EL(25)A/45