Class 3 Medicines Recall: Latanoprost Timolol Eye drops

FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)

Product information

MDR number

MDR 076-04/18

Company name

FDC Pharma

Product description

Latanoprost / Timolol 50 micrograms/mL + 5mg/mL

Eye Drops, Solution

PL 35638/0004

Batch number/expiry

Batch Number Expiry Date Pack Size First Distribution
087B087 01/2019 1 x 2.5 mL 15/06/2017

Brief description of the problem

FDC Pharma are recalling the above batch due to an out of specification result for an unknown impurity during stability testing.

Advice for healthcare professionals

Stop dispensing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.

Advice for wholesalers and distributors

Refer to the instructions provided by FDC Pharma. Stop distributing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.

Medical Information enquiries and stock enquiries

For medical and stock availability information enquiries please contact Mr Santosh Amoncar:(0)1489 565 222; 07903203039 or fdcil@btconnect.com

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Class 3 Medicines Recall: Latanoprost Timolol Eye drops

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 2 May 2018