;

Media Statement

2/1/2021

In August 2020, Laboratorios Silesia initiated the recall of batch B20034A – a clinical format that was only distributed to the National Supply Center (CENABAST) – of the combined oral contraceptive Anulette® CD due to irregularities in the blisters that resulted in empty cavities and misplaced tablets. In early September 2020, the laboratory decided to conduct a voluntary recall of a second batch, B20035A, after identifying a similar irregularity. A total of 12 defective packs were found in both batches. The reason for the irregularities was increased tension in the blister foil which caused some tablets to move during the packaging process. This issue has been identified and fixed.

These irregularities were visible through the transparent blister foil and were detected in 12 blisters out of a total of 276,890 across both batches. The contraceptive efficacy of the tablets was never compromised.

Laboratorios Silesia recalled both batches after becoming aware of this issue. As a preventative measure, the Institute of Public Health (ISP) announced a temporary suspension from the register of approved products on 8 September 2020. This was lifted on 24 November 2020 because all quality requirements had been met by that point.

The affected batches were delivered to the clinical setting where the product is dispensed individually. This means healthcare professionals were able to visually identify any anomalies before handing the blister to the user.

The type of withdrawal instructed by the authority was carried out according to international standards and at the level of the health service, not at the level of users.

Laboratorios Silesia investigated the matter and has shared the results with the Institute of Public Health (ISP). Likewise, preventative and control measures have been implemented to ensure manufacturing quality and make certain that all requirements from the health authority were fulfilled. Anulette® CD remains available to users and providers with no restrictions for manufacturing and distribution.

The clinical efficacy of modern contraceptives does not reach 100% due to various factors described in multiple studies and is measured by the Pearl Index. According to studies, the pregnancy rate during the first year of use of a combined oral contraceptive reaches 5.5 to 7 per 100 women/year (WHO 2018).

Patient safety is our highest priority. Strict pharmacovigilance and quality management systems enabled immediate coordination with the authorities and providers. We continue to provide access to safe and effective oral contraceptives to women and their physicians.

Fabia Kehren

Head External Communications and Editorial Management

Grünenthal GmbH


52099 Aachen

E-Mail Fabia.Kehren@grunenthal.com

Phone +49 241 569-3269