Leakages in Ampoules cause Recalls

Recommendation

17-19 September 2024

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Again, there is a recall of sterile ampoules in Switzerland. The manufacturer stated a possible leakage as reason for the recall. The area concerned seems to be the breaking point as was the case in the recall by Streuli Pharma in 2013. This case was presented at the ECA Conference "Particles in Parenterals and beyond" in Copenhagen in September 2014. Product had crystallized on the outer surface of the ampoule at the breaking point. Although the leakage could not be verified with any method available and no contamination of the product came to be known it was not possible to exclude that microorganisms could penetrate into the ampoule. Consequently, non-sterility could not be excluded. According to a statement from Streuli Pharma this packaging material problem could not be solved so that they had to change the primary packaging material within a very short time.

You can find the case which occurred only now but is described in an analogous way at the page of Swissmedic.

Another sterile medicinal product had to be recalled in Switzerland because of crystallization of the product (particle formation) in the solution for injection.

Batches of another product were withdrawn from the market because of possible metal particles already in October.