Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17)

FDC International Ltd are recalling specific batches of Sodium Cromoglicate 2% w/v Eye Drops 13.5ml and Murine Hayfever Relief 2% w/v Eye Drops 10ml due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some bottles.

Product information

MDR number

MDR 072-05/17

Company name

FDC International Ltd

Product description

Sodium Cromoglicate 2% w/v Eye Drops 13.5ml

Eye Drops, Solution

PL 15872/0010

Murine Hayfever Relief 2% w/v 10ml Eye Drops (GSL)

Eye Drops, Solution

PL 15872/0008

Batch number/expiry

Product Batch Number Expiry Date First Distribution
Sodium Cromoglicate 2% w/v Eye Drops 13.5ml 086I069 08/2019 03/03/2017
Murine Hayfever Relief 2% w/v Eye Drops 10ml 086L075 11/2018 11/05/2017

Brief description of the problem

FDC International Ltd is recalling the above batches due to the presence of a precipitate, which has been identified as Sodium Cromoglicate, in some bottles.

Advice for healthcare professionals and wholesalers

All remaining packs of the listed batches should be quarantined and returned to the original supplier.

Medical Information enquiries and stock enquiries

For medical and stock availability information enquiries please contact Santosh Amoncar: 01489 565 222; 07903 203039 or email fdcil@btconnect.com.

Download document

MDR 072-05/17

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 community pharmacists, hospital pharmacists and dispensing general practitioners. It is not necessary to forward this notice to non-dispensing GPs.

Published 30 July 2018