Company led medicines recall: Dotarem solution for injection (10ml Vial) - PL 12308/0016
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| Type | Medicines recall/notification |
|---|---|
| Issued | 17 Nov 2021 |
| Product licences | PL 12308/0016 |
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):
Company Contact for stock enquiries
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