Merck Sharp & Dohme Limited is recalling specific batches due to the presence of Ralstonia pickettii in recent batches that were manufactured. These specific 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 listed 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 listed 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.
Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts