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 [email protected]
Phone number: 01992 452094
For more information or medical information at [email protected]
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.
Download document