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| The United Kingdom: Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, Opdivo 10 mg/ml concentrate for solution for infusion (nivolumab) (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of Opdivo 10 mg/ml concentrate for solution for infusion (nivolumab) (batch number: 8053520).
This defect has been reported in vials manufactured from the same bulk batch in another market, although no defects have been reported in the United Kingdom market.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-bristol-myers-squibb-pharmaceuticals-limited-opdivo-10-mg-slash-ml-concentrate-for-solution-for-infusion-nivolumab-el-24-a-slash-11
In Hong Kong, Opdivo Concentrate For Solution For Infusion 40mg/4ml (HK-64231), Opdivo Concentrate For Solution For Infusion 100mg/10ml (HK-64232) and Opdivo Concentrate For Solution For Infusion 240mg/24ml (HK-67733) are pharmaceutical products registered by Bristol-Myers Squibb Pharma (HK) Ltd. All products are prescription-only medicines. As confirmed by the company, the batch recalled in the United Kingdom (batch number: 8053520) and the other affected vials (i.e. vials manufactured from the same bulk batch) have not been imported into Hong Kong.
Ends/Friday, Apr 5, 2024
Issued at HKT 15:00
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