Class 4 medicines defect information: chloramphenicol 0. 5% w/v antibiotic eye drops (mdr 105-03/19)

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’.

CONTENTS * Company name * Product description * Brief description of the problem * Advice for healthcare professionals * Further information * Download the document 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: [email protected] 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. UPDATES TO THIS PAGE Published 9 April 2019 Contents