Brazil tells Bayer to recall 13 lots of Gynera contraceptive

By Gareth Macdonald contact

- Last updated on GMT

iStock/Vepar5
iStock/Vepar5

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: Regulatory & Safety, Regulations, QA/QC

Related news

Show more

Related products

How to resolve sticking issues in tablet production

How to resolve sticking issues in tablet production

I Holland Limited - Tabletting Science | 24-Jun-2019 | Case Study

Tablet sticking is one of the most common problems in tablet manufacture. Find out how I Holland used the TSAR scientific predictive model and expert tablet...

How to measure powder and granule flow properties

How to measure powder and granule flow properties

Stable Micro Systems | 01-Apr-2019 | Technical / White Paper

Being able to predict, optimise and control powder flow is of prime importance to manufacturers in ensuring high quality standards. Download this free...

Related suppliers

Follow us

Products

View more

Webinars