COSOPT preservative-free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container - difficulties with administration

(Merck Sharp and Dohme) Increase in the number of adverse events and product complaints following introduction of ‘winged’ presentation - class 2 action within 48 hours. (EL (14)A/02)

17 February 2014

Class 2 medicines recall

Action within 48 hours

Pharmacy level recall

MDR 05-09/13

Product details

Merck Sharp & Dohme Limited

COSOPT Preservative-Free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container

(Dorzolamide / Timolol)

PL 00025/0698

Alert details

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 The ‘winged’ presentation is therefore being withdrawn.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.

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