Company led drug alert - Optiray庐 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray庐 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庐 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) Optiray庐 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): [email protected] and [email protected]
Email (stock enquiries): [email protected]