| AMOXICILLIN | MHRA | 2009-8-18 | AMOXICILLIN-MHRA-2009-8-18 | Statement Karib Kemipharm (also trading as Karib Ltd) is carrying out precautionary medicine recalls at wholesale and pharmacy level.
This follows evidence that the medicines, contract manufactured in India, were exposed to unsatisfactory conditions during shipment by sea, potentially causing them to deteriorate over time.
At present there is no specific evidence to suggest that the medicines are not safe for patient use.
Products entering the EU from non-EU countries have to be tested on import.
These medicines have passed the required tests.
However, testing is a sampling activity which examines a sample of the batch and only relects the condition at the time of testing.
Further testing is being carried out to obtain more information about the risks and potential problems.
The MHRA has issued Class 2 Drug Alerts to healthcare professionals to support these precautionary recalls.
The recalls only relate to the medicines and the licence holders that are specified in the published drug alerts.
Patients who have these medicines do not need to worry and should continue taking their medication.
Karib Kemi Pharm Ltd, the marketing authorisation holder, are recalling all unexpired stock of the above products due to unsatisfactory shipment conditions during sea transit from their overseas contract manufacturers.
All unexpired stock of the listed products and batches should be quarantined and returned for credit.
|