Class 2 Medicines Recall: Merck Sharp & Dohme Limited, Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion, EL (20)A/60

Merck Sharp & Dohme Limited is recalling specific batches of Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion as a precautionary measure due to the presence of Ralstonia pickettii in recent batches manufactured

PL Number(s)

EU/1/15/1032/001

MDR Number

MDR 060-12/20

Company Name

Merck Sharp & Dohme Limited

Product description

Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion

Batch Number Expiry Date Pack Size First Distributed
S036625 31/12/2021 10 X 20ml April 2020
S038424 31/12/2021 10 X 20ml January 2020
S041245 31/12/2021 10 X 20ml April 2020
T001191 31/12/2021 10 X 20ml September 2020
T001192 31/12/2021 10 X 20ml March 2020
T031915 30/04/2022 10 X 20ml November 2020

Active Pharmaceutical Ingredient: ceftolozane sulfate / tazobactam sodium

Brief description of the problem

Merck Sharp & Dohme Limited is recalling the above batches 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 R. pickettii is found to be present, the risk that these products would contain viable R. pickettii in a level that could cause serious adverse health consequences is considered to be low.

R. 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.

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

If patients experience a worsening of symptoms or other suspected side effects during therapy with Zerbaxa, these should be reported via the Yellow Card scheme.

Further Information

For stock control enquiries please contact customerservice.msduk@msd.com

Phone number: 01992 452094

For more information or medical information at medicalinformationuk@msd.com

Phone number: 01992 467272

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

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Class 2 Medicines Recall: Merck Sharp & Dohme Limited, Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion, EL (20)A/60

Published 16 December 2020