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.