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 Numbers:
- 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
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.