Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Merck Sharp & Dohme Limited, Zerbaxa 1g／0.5g Powder for Concentrate for Solution for Infusion |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Merck Sharp & Dohme Limited is recalling 6 batches of Zerbaxa (ceftolozane sulfate/tazobactam sodium) 1g/0.5g Powder for Concentrate for Solution for Infusion (batch number: S036625, S038424, S041245, T001191, T001192 and T031915) due to the presence of Ralstonia pickettii in recent batches that were manufactured. The above batches are recalled as a precautionary measure whilst investigations into the microbiological quality of the distributed products are underway.
The potential for contamination of the above batches is low. If Ralstonia pickettii is found to be present, the risk that these products would contain viable Ralstonia pickettii in a level that could cause serious adverse health consequences is considered to be low.
Ralstonia pickettii is a gram-negative, non-motile, non-spore-forming, rod-shaped bacteria found in soils, rivers, and lakes. It is also present in biofilms bacteria (collective of one or more types of microorganisms that can grow on surfaces) in industrial plastic water systems.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-merck-sharp-and-dohme-limited-zerbaxa-1g-slash-0-dot-5g-powder-for-concentrate-for-solution-for-infusion-el-20-a-slash-60
In Hong Kong, Zerbaxa Powder For Concentrate For Solution For Infusion 1g/0.5g (HK-65156) is a pharmaceutical product registered by Merck Sharp & Dohme (Asia) Ltd (MSD), and is a prescription-only medicine. As confirmed with MSD, the affected batches in the United Kingdom have not been imported into Hong Kong.
On 17 Dec 2020, the Department of Health (DH) endorsed MSD to recall Zerbaxa Powder For Concentrate For Solution For Infusion 1g/0.5g (HK-65156) from the market. A press statement was issued on the same day. DH will continue to monitor the recall.
Ends/Thursday, Dec 17, 2020
Issued at HKT 16:00
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