Class 4 MHRA Drug Alert – Chloramphenicol 0.5% W/V Antibiotic Eye Drops (Martindale Pharmaceuticals Limited)

Class 4 MHRA Drug Alert – Chloramphenicol 0.5% W/V Antibiotic Eye Drops (Martindale Pharmaceuticals Limited)

April 9, 2019

Drug Alert No: El (19) A/09
Date Issued: 9th April 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for Chloramphenicol 0.5% W/V Antibiotic Eye Drops (Martindale Pharmaceuticals Limited)

PL 00156/0109

Batch Numbers:

1810248 1901208 1811249 1901854 1812583 1902389
1811060 1901756 1901759 1812310 1901163 1902418
1811129 1901757 1812309 1902375 1901164 1902601

Martindale Pharmaceuticals, have informed MHRA, that all unexpired batches of  Chloramphenicol 0.5% W/V Antibiotic Eye Drops PL 00156/0109, legal status P, are missing Braille from the carton, and the Patient Information Leaflet (PIL) states the legal status as POM.

In order to maintain supply, the affected batches are not being recalled.

The content of the PIL for the P version is similar to the POM version but there are some differences in the way the information is expressed.

Community pharmacy teams should replace the PIL with the correct one which can be downloaded here.

View the full alert here

For any enquiries, please contact Martindale / Ethypharm Customer Services email: licensed@ethypharm.com

 



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