Company led drug alert - Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032)

Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of the pre-filled syringe and tubing catheter.

Product description

Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032)

Lot number/expiry

Batch Number Expiry Date Pack Size First Distributed
20H1482U 31 July 2023 350mg/75ml x 10 24 September 2020
20H1452U 31 July 2023 300mg/75ml x 10; 300mg/100ml x 10 7 September 2020
20F1342U 31 May 2023 350mg/100ml x 10 7 August 2020
20F1312U 31 May 2023 300mg/100ml x 10 20 August 2020
20F1292U 31 May 2023 300mg/75ml x 10 11 August 2020

MDR Number

MDR 069-10/20

CLDA Number

CLDA (20)A/03

Company name

Guerbet Laboratories Limited

Brief description of the problem

Guerbet Laboratories Limited is recalling the above batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of the pre-filled syringe and tubing catheter. In some cases this has resulted in leakages of contrast media during use.

Advice for Healthcare Professionals and Wholesalers

Remaining stock of these batches should be quarantined and returned to Guerbet for credit.

Company contacts for further information

For medical information and stock enquiries, please contact Guertbet Laboratories Limited:

Tel: 01217338542

E-mail (medical enquiries): uk.sales@guerbet.com and Krupa.mehta@guerbet.com

Email (stock enquiries): uk.sales@guerbet.com

Published 22 October 2020