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)
- The problem
- 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.
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
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
Updated 22 October 2020. This page summarises an official notice. Details can change – always follow the official notice.