CLDA Number

CLDA (20)A/01

MDR Number

MDR 019-02/20

Company Name

Glenmark Pharmaceuticals Europe Ltd.

Product Description

Iohexol 350mg/ml solution for injection - PL 25258/0247

Iohexol 300 mg I/ml solution for injection - PL 25258/0246

Batch Number/Expiry

Iohexol 350mg/ml solution for injection - PL 25258/0247

Batch Number Expiry Date Pack Size First Distributed 1805641 07/2021 100 ml 14/12/2018 1806771 09/2021 50 ml 14/12/2018

Iohexol 300mg/ml solution for injection - PL 25258/0246

Batch Number Expiry Date Pack Size First Distributed 1805640 06/2021 100 ml 14/12/2018 1805752 07/2021 75 ml 14/12/2018 1806007 08/2021 50 ml 14/12/2018

Brief Description of Problem

As a precautionary measure, Glenmark Pharmaceuticals is recalling the above lots to wholesaler and pharmacy level due to an out of specification result from the ongoing stability studies. The out of specification result for all batches of Iohexol distributed in United Kingdom are up to 4% over the upper specifications limits for content. (105%).

Remaining stock of this batch should be quarantined and returned to the original supplier for credit.

For medical information enquiries, please contact: Glenmark medical information: Tel: 0800 458 0383 e-mail: medical_information@glenmarkpharma.com

For stock enquiries, please contact: Matthew Jeffery Tel: 01923 202950 | (Extn) 3010 e-mail: Matthew.Jeffery@glenmarkpharma.com