Brazil tells Bayer to recall 13 lots of Gynera contraceptive

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Combined oral contraceptive pill

Anvisa has ordered Bayer to recall 13 lots of the contraceptive Gynera (gestodene + ethinyl estradiol) over concerns about stability data.

The Brazilian regulator announced the suspension yesterday (here​ in Portuguese), explaining that: “The lots of contraceptives manufactured by Bayer SA presented results that do not comply with current sanitary legislation​.”

According to a recall notice (here​ in Portuguese) posted by Bayer, test data revealed a change in the stability profile of the product.

The Germany-headquartered drug firm said: “The change in the profile of the stability study was confirmed in the results obtained in our last quality control analyses​.”

Although there was such a change … the efficacy and safety of the contraceptive was not compromised​” it said, adding that “concentrations of the hormones in Gynera are sufficient to ensure the maintenance of the contraceptive efficacy standards expected by the method​.”

Bayer also said it has temporarily suspended production of Gynera while it investigates the issue.

Related topics: Markets & Regulations, Regulations, QA/QC

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