Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: Chloramphenicol 0.5% W／V Antibiotic Eye Drops |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Martindale Pharmaceuticals has informed MHRA of two issues with all unexpired batches of Chloramphenicol 0.5% W/V Antibiotic Eye Drops, legal status ‘P’. The braille is missing from the carton and the packs contain the Patient Information Leaflet (PIL) for the product with legal status ‘POM’. The affected batches are: 1810248, 1811060, 1811129, 1811249, 1812309, 1812310, 1812583, 1901163, 1901164, 1901208, 1901756, 1901757, 1901759, 1901854, 1902375, 1902389, 1902418 and 1902601.
In order to maintain supply, the affected batches are not being recalled. The content of the PIL for the ‘P’ version is similar to that for the ‘POM’ version but there are some differences in the way the information is expressed.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-chloramphenicol-0-5-w-v-antibiotic-eye-drops-mdr-105-03-19
In Hong Kong, Chloramphenicol Eye Drops 0.5% (Famar S.A.) (HK-09064) is a pharmaceutical product registered by The International Medical Company Limited (The International), and is a prescription-only medicine. As confirmed with The International, the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Apr 10, 2019
Issued at HKT 16:00
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