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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. »Ê¹ÚÌåÓýapp 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: [email protected]

Company Contact for stock enquiries

For stock enquiries, please contact: Matthew Jeffery Tel: 01923 202950 | (Extn) 3010 e-mail: [email protected]