Company led drug alert – Iohexol solution for injection (350mg/ml and 300 mgI/ml)
Glenmark Pharmaceuticals is recalling specific batches as a precautionary measure.
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: 1805641
- Expiry date: 07/2021
- Pack size: 100 ml
- First distributed: 14/12/2018
- Batch number: 1806771
- Expiry date: 09/2021
- Pack size: 50 ml
- First distributed: 14/12/2018
Iohexol 300mg/ml solution for injection - PL 25258/0246
- Batch number: 1805640
- Expiry date: 06/2021
- Pack size: 100 ml
- First distributed: 14/12/2018
- Batch number: 1805752
- Expiry date: 07/2021
- Pack size: 75 ml
- First distributed: 14/12/2018
- Batch number: 1806007
- Expiry date: 08/2021
- Pack size: 50 ml
- First distributed: 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%).
Company Contact for medical information enquiries
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
Company Contact for stock enquiries
For stock enquiries, please contact: Matthew Jeffery Tel: 01923 202950 | (Extn) 3010 e-mail: Matthew.Jeffery@glenmarkpharma.com