Information Update: In Vitro Fertilization Product (Endometrin) Recalled Due to Possible Problems with Effectiveness
(firmenpresse) - OTTAWA, ONTARIO -- (Marketwired) -- 11/22/13 -- Ferring Pharmaceuticals, in consultation with Health Canada, is voluntarily recalling two lots of Endometrin (100 mg progesterone tablet), a prescription medication used during in vitro fertilization. The lots (0804.209A-1 and 0804.219A-1) were released in July and September of 2013, according to the company.
The voluntary recall is a precautionary measure due to the potential damage of tablets from a packaging equipment malfunction that has caused brown discolouration of some tablets and/or blister packs. As a result, the company has informed Health Canada that the discoloured tablets could potentially be altered, which could affect the therapeutic effectiveness of the product and lead to early pregnancy loss.
According to the company, the problem has occurred with different lots in other countries but has not been seen with the lots in Canada to date.
Health Canada has not received any reports of adverse events as of November 15, 2013 associated with Endometrin. Ferring Pharmaceutical has also indicated that it has not received any reports of adverse events for this product.
Health Canada is monitoring the recall and will update Canadians should new information be identified.
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Datum: 22.11.2013 - 14:12 Uhr
Sprache: Deutsch
News-ID 1286312
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