MHRA发布二级药品召回，Hameln Pharma召回克拉霉素500 mg输注用浓溶液粉末制剂特定批次（EL(25)A/53）

Contents

1. DMRC reference number
2. Marketing Authorisation Holder
3. Medicine Details
   1. Clarithromycin 500 mg powder for concentrate for 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-37790612

Marketing Authorisation Holder

Hameln Pharma ltd

Medicine Details

Clarithromycin 500 mg powder for concentrate for solution for infusion

PL: 01502/0135

Active ingredient: clarithromycin lactobionate

SNOMED code: 36236311000001104

GTIN: 05016386000218

Affected Lot Batch Numbers

Background

Hameln Pharma Ltd is recalling the batches of Clarithromycin 500 mg powder for concentrate for solution for infusion listed in the table. Following an inspection of the clarithromycin lactobionate raw material manufacturer, the certification of suitability for use in medicines was withdrawn due to non-compliance with Good Manufacturing Practice.

The affected batches of Clarithromycin 500 mg powder for concentrate for solution for infusion are listed in the table above.

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.

Hameln Pharma Ltd has not received an increase in reports of adverse events or product quality complaints in connection with these batches. The recall is being undertaken as a precautionary measure.

The recall only applies to the batch numbers listed in the table, which were manufactured with the affected raw material. Other batches of Clarithromycin 500 mg powder for concentrate for solution for infusion are not impacted.

Replacement batches of Clarithromycin 500 mg powder for concentrate for solution for infusion are available from Hameln Pharma Ltd and ongoing supplies will be maintained.

Advice for Patients:

Patients are not required to take any action. This product is administered by healthcare professionals in a hospital or healthcare setting.

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)1452 621 661.

For stock control enquiries please email [email protected] , or telephone +44 (0)1452 621 661.

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: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53