Class 2 Medicines Recall (action within 48 hours): COSOPT Preservative-Free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container – Merck Sharp & Dohme Limited (EL (14)A/02)
17 February 2014
Merck Sharp & Dohme Limited
COSOPT Preservative-Free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container (Dorzolamide / Timolol)
|Batch number||Expiry Date||Pack size||First distributed|
|MK13D002||30 April 2015||60 single dose containers||9 September 2013|
|MK13D004||30 April 2015||60 single dose containers||4 July 2013|
Merck Sharp and Dohme is recalling the above batches due to an increase in the number of adverse events and product complaints relating to difficulties with administration received following the introduction of this ‘winged’ presentation in July 2013. A modified design of pipette, which has wings set back from the tip and a more prominent conical tip, has now been introduced as an interim measure to address complaints with the ‘winged’ container. The ‘winged’ presentation is therefore being withdrawn.
Pharmacists are asked to quarantine any remaining stocks of the above batches and return them to the original wholesaler for credit. For stock enquiries please contact MSD Customer Care on 01992 452094.
For medical information enquiries, please contact MSD Medical information services on 01992 467272.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
Defective Medicines Report Centre
151 Buckingham Palace Road
Telephone +44 (0)20 3080 6574
MHRA Distribution (further recipients by cascade): N/A