Medicine recalls
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| The United Kingdom: Company led medicines recall: Dotarem Solution for Injection (10ml vial) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Guerbet Laboratories Ltd is recalling two batches of Dotarem Solution for Injection (10ml vial) (gadoteric acid) (batch number: 21GD006B04, 21GD006C01) 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 10ml vials 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/company-led-medicines-recall-dotarem-solution-for-injection-10ml-vial-pl-12308-slash-0016
In Hong Kong, Dotarem Inj 377mg/ml (vial) (HK-41578) is a pharmaceutical product registered by Guerbet Asia Pacific Ltd (Guerbet) and is a prescription-only medicine. As confirmed with Guerbet, the above affected batches have not been imported into Hong Kong.
On 12 Nov 2021, the Department of Health (DH) endorsed Guerbet to recall a batch of Dotarem Inj 377mg/ml (10ml vial) (HK-41578) (batch number: 21GD054A) from the market as a precautionary measure due to a potential quality defect of the product. A recall statement was issued on the same date.
Ends/Thursday, Nov 18, 2021
Issued at HKT 15:00
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