Class 2 Drug Alert (Action within 48 hours): Karib Kemi Pharm Ltd - Multiple product Drug Alert - EL (09)A/23

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Dear Healthcare Professional,

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. This obviously takes time and some problems may only be detected as the product ages. The recall action taken now should minimise the risk to the patient. 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. The same medicines which are marketed by other companies are not affected by these alerts. Patients who have these medicines do not need to worry and should continue taking their medication. If patients have any concerns, they should speak to the pharmacist who dispensed the medicine.

Multiple product Drug Alert

Product Name	PL No.
Amoxicillin Caps 250mg	18224/0004
Amoxicillin Caps 500mg	18224/0005
Atenolol Tabs 50mg	18224/0018
Atenolol Tablets 100mg	18244/0019
Ciprofloxacin Tablets 250mg	18224/0008
Ciprofloxacin Tablets 500mg	18244/0009
Fluoxetine Caps 20mg	18224/0059
Paracetamol Tabs 500mg	18224/0003
Phenoxymethylpenicillin Potassium Tabs 250mg	18224/0049
Ranitidine Tabs 75mg	18224/0028
Ranitidine Tabs 150mg	18224/0006
Ranitidine Tabs 300mg	18224/0007

Details of over one hundred batches are attached to this document as Appendix 1. Please note the Sandoz livery products are listed in line numbers 68, 70 and 72 of Appendix 1.

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. However, care needs to be taken to ensure only those specific batches listed in this drug alert are returned. There are a number of other batches and products which have been transported by air and are not subject to recall action.

For any Medical Information enquiries related to this case please call Karib Kemi Pharm Ltd on 07732 166641 or 07732 166891

For enquiries related to stock returns and credit please call Karib Kemi Pharm Ltd on the numbers in the previous paragraph.

Further details of the products and liveries involved are attached as Appendix 1 (in PDF only). This list has been provided by Karib Kemi Pharm Ltd as all remaining in-date stock which has been shipped by sea.

Further information is attached as Questions and Answers in Appendix 2 (in PDF only).

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary Care Trusts are requested to forward this to relevant clinics, General Practitioners and Community Pharmacists.

Yours faithfully
Ian Holloway

MHRA DMRC Manager

MHRA Distribution (further recipients by cascade):

Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)