Medicine recalls
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| The United Kingdom: 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 |
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Merck Sharp and Dohme is recalling the above product with batch number MK 13D002 and MK 13D004 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 The "winged" presentation is therefore being withdrawn.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Publications/Safetywarnings/../CON380456
In Hong Kong, Cosopt Preservative Free Eye Drops is not a registered pharmaceutical product. However, two licensed drug wholesalers, namely PWP International (HK) Ltd (PWP) and Vantone Medical Supplies Co Ltd (Vantone) have respectively imported 140 boxes and 6 boxes of the products with batch number MK13D001, MK13C004 and MK13C002 (imported by PWP) and 2086590 (imported by Vantone) for the treatment of particular patients. Department of Health (DH) had endorsed PWP and Vantone to initiate a voluntary recall for the said batches on 13 Feb 2014 and related news was posted on the Drug Office website on the same day. News related to the problematic design of Cosopt Preservative-Free Eye Drops have been released by MHRA and Health Canada on 28 Jan 2014 and 7 Feb2014 respectively, and were posted on the Drug Office Website on 29 Jan 2014 and 8 Feb 2014. With regard to the batches concerned this time, PWP and Vantone have imported the products of batch number MK 13D002 only for treatment of particular patients. DH endorses PWP and Vantone to extend the recall further to cover the affected batches and will closely monitor the recall. So far, DH has not received any report on adverse event related to the product.
Ends/ Tuesday, February 18, 2014
Issued at HKT 12:00
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