Serono recalls some batches of Crinone

5 April 2001

Switzerland's Serono is voluntarily recalling a number of batches ofCrinone (progesterone vaginal gel) 4% and 8% (for use in the treatment of infertility in women) due to a drug application problem in some applicators.

This recall is a response to complaints which subsequently were investigated by Columbia Laboratories, the manufacturer of Crinone. An investigation by Columbia Labs has determined that the gel may change in its consistency over time in these recalled batches. This may result in the gel being partially expelled when opening the applicator prior to administration, according to a Serono statement.

Serono acquired the exclusive rights throughout most of the world to Crinone, which achieved sales of $27.4 million in 2000, from Wyeth-Ayerst in 1999.

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