Company led medicines recall: Dotarem solution for injection (10ml Vial) - PL 12308/0016

Guerbet Laboratories Ltd is recalling the above batches of Dotarem 10ml vials due to the potential risk of a sterility break.

CLMR Number

CLMR (21)A/08

MDR Number

MDR 167-11/21

Company Name

Guerbet Laboratories Ltd

Product description

Dotarem Solution for Injection (10ml Vial) - PL 12308/0016

Lot Number/Expiry

Batch Number Expiry Date Pack Size First Distributed
21GD006B03 December 2023 X1 March 2021
21GD006C01 December 2023 X1 June 2021

Active ingredient: Gadoteric Acid 279.32 mg/ml

Brief Description of Problem

Guerbet Laboratories Ltd is recalling the above batches of Dotarem 10ml vials, due to the potential risk of a sterility break, based on the evidence of external leaks of the solution (dry product on the external surface of the vials).

The root cause of the problem relates to a defect of the glass vial neck supplied by SGD Saint-Gobain. After investigation of the retained samples, two batches of Dotarem 10 mL Vials (# 21GD006) were identified.

As a precautionary measure, Guerbet has decided to trigger a batch recall for the impacted batches. Other vial sizes of Dotarem (5, 15, 20mL) are not affected by this problem.

This product is supplied to hospital pharmacies only for use in MRI scanning.

Remaining stock of the above batch should be quarantined and returned to the company directly.

Company Contact for medical information enquiries

For medical information enquiries, please contact James Bradley (GDP RP):

james.bradley@guerbet.com

Company Contact for stock enquiries

For stock information enquiries,

UK Customer Services

uk.sales@guerbet.com

Updates to this page

Published 17 November 2021