Class 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53
Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.
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
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 23J097 | 30/09/2027 | 10 | 07/11/2023 |
| 23J098 | 30/09/2027 | 10 | 11/12/2023 |
| 23J099 | 30/09/2027 | 10 | 08/01/2024 |
| 23J100 | 30/09/2027 | 10 | 09/02/2024 |
| 24A227 | 30/11/2027 | 10 | 10/05/2024 |
| 24A230 | 31/12/2027 | 10 | 12/08/2024 |
| 24E038 | 31/01/2028 | 10 | 22/08/2024 |
| 24E039 | 29/02/2028 | 10 | 17/09/2024 |
| 24E040 | 29/02/2028 | 10 | 03/10/2024 |
| 24G130 | 30/04/2028 | 10 | 11/11/2024 |
| 24G330 | 30/04/2028 | 10 | 28/11/2024 |
| 24G331 | 30/04/2028 | 10 | 03/12/2024 |
| 24G333 | 30/06/2028 | 10 | 30/12/2024 |
| 24I243 | 31/07/2028 | 10 | 07/01/2025 |
| 24I245 | 31/07/2028 | 10 | 20/01/2025 |
| 24I400 | 31/07/2028 | 10 | 03/02/2025 |
| 24I402 | 30/09/2028 | 10 | 12/02/2025 |
| 24I403 | 30/09/2028 | 10 | 04/03/2025 |
| 24I404 | 30/09/2028 | 10 | 25/03/2025 |
| 24I418 | 30/09/2028 | 10 | 14/04/2025 |
| 24K161 | 31/10/2028 | 10 | 28/04/2025 |
| 24K162 | 31/10/2028 | 10 | 16/05/2025 |
| 24K163 | 31/10/2028 | 10 | 27/05/2025 |
| 24K164 | 30/11/2028 | 10 | 27/05/2025 |
| 24K165 | 30/11/2028 | 10 | 16/06/2025 |
| 24K166 | 30/11/2028 | 10 | 08/07/2025 |
| 24K167 | 30/11/2028 | 10 | 04/08/2025 |
| 24K168 | 30/09/2028 | 10 | 24/04/2025 |
| 25D674 | 31/03/2029 | 10 | 26/08/2025 |
| 25D675 | 31/03/2029 | 10 | 19/09/2025 |
| 25F174 | 31/05/2030 | 10 | 09/10/2025 |
| 25F175 | 31/05/2030 | 10 | 31/10/2025 |
| 25F263 | 31/05/2030 | 10 | 19/11/2025 |
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of the clarithromycin lactobionate raw material manufacturer, the certification of suitability for use in medicines was withdrawn due to non-compliance with Good Manufacturing Practice.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 drug.safety@hameln-pharma.co.uk or telephone +44 (0)1452 621 661.
For stock control enquiries please email customer.services@hameln-pharma.co.uk , 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
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