Feb 23 • 11:23 UTC 🇧🇷 Brazil G1 (PT)

Anvisa determines the recall of antibiotic after bottle exchange in batch

The Brazilian health regulator Anvisa has ordered the recall and immediate suspension of the injectable antibiotic Kefadim due to a packaging error that led to the mislabeling of its contents.

The Brazilian Health Regulatory Agency, Anvisa, has mandated the recall and immediate halt of the sale, distribution, and use of a specific batch of the injectable antibiotic Kefadim. This action comes after Anvisa confirmed a packaging error that resulted in the mixing of medications, specifically indicating that the antibiotic Kefazol was present in packaging labeled as Kefadim. The recall affects batch number 111770C of the Kefadim 1 g powder for injection, produced by Antibióticos do Brasil Ltda.

This decision was taken to protect public health, as the presence of the wrong medication could lead to incorrect treatment and potential health risks for patients. Anvisa's report explicitly highlights the quality deviation caused by the packaging failure, which posed a significant safety concern. The authority's swift response underscores its role in monitoring and ensuring drug safety within Brazil's healthcare system.

As the recall is implemented, healthcare providers and consumers are urged to pay close attention and return any affected products. This incident calls for a review of manufacturing and packaging processes by the involved company to prevent similar occurrences in the future. The implications of this case go beyond immediate health risks, as they reflect on the integrity of pharmaceutical manufacturing practices and regulatory oversight in Brazil.

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