Class 4 Medicines Defect Information: Chloramphenicol 0.5% W/V Antibiotic Eye Drops (MDR 105-03/19)

Martindale Pharmaceuticals has informed us of two issues with all unexpired batches of the above product, PL 00156/0109, 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’.

Company name

Martindale Pharmaceuticals Limited

Product description

Chloramphenicol 0.5% W/V Antibiotic Eye Drops PL 00156/0109

All unexpired batches are affected

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

Brief description of the problem

  • the braille is missing from the carton

  • packs contain the Patient Information Leaflet (PIL) for the product with legal status ‘POM’

Advice for healthcare professionals

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. The correct PIL for the ‘P’ product can be downloaded via the following link: https://www.medicines.org.uk/emc/product/9662/pil

Further information

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

Download the document

Drug alert: Chloramphenicol 0.5% W/V Antibiotic Eye Drops (MDR 105-03/19)

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to relevant clinics, community pharmacists and dispensing General Practitioners for information.

Published 9 April 2019