Novartis and Diagnostics Srl recall meningitis vaccine kit
Novartis Vaccines and Diagnostics Srl are recalling batches of Menjugate Kit as a precaution after samples from two batches were found to contain a bacterium.
Novartis Vaccines and Diagnostics Srl are recalling batches of Menjugate Kit as a precaution after samples from two batches were found to contain a bacterium.
The precautionary move follows an initial failure of a sterility test carried out as part of a shipping validation study of the batch of aluminium hydroxide solvent used in them. This batch passed its sterility test at the time of release.
The recalled batches of the Menjugate Kit were manufactured in Italy and then shipped to various countries. Some 21,000 doses have already been removed from the shelves.
Novartis are investigating the root cause for the non-conforming sterility result.