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Anvisa bans counterfeit Dysport and suspicious Keytruda lots
Brazil's National Health Surveillance Agency (Anvisa) has ordered the seizure and prohibited the sale, distribution, and use of specific medication lots due to concerns over falsification.
Anvisa classified lot 025155 of Dysport, a botulinum toxin used for aesthetic and therapeutic procedures, as counterfeit. The manufacturer, Beaufour Ipsen, identified several irregularities, including incorrect expiration dates, mismatched barcodes, different vial shapes, and non-standard packaging graphics.
Additionally, Anvisa has prohibited two lots of the cancer treatment Keytruda (pembrolizumab) — Z005197 and Z012354 — following reports from Merck Sharp & Dohme (MSD) regarding suspected falsification and physical inconsistencies in the packaging and units.
In separate regulatory news, Anvisa approved Emrelis (telisotuzumab vedotin), an AbbVie drug for advanced or metastatic non-small cell lung cancer. Brazil is the second country to authorize this therapy, following the United States.
Entities
AbbVie · Anvisa · Beaufour Ipsen · Brazil · Dysport · Keytruda · Merck Sharp & Dohme
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 3 SOURCES] Anvisa prohibited the sale, distribution, and use of Dysport lot 025155. horams.com.br · aredacao.com.br · contilnetnoticias.com.br
- [● 3 SOURCES] Beaufour Ipsen identified Dysport lot 025155 as having incorrect expiration dates and mismatched barcodes. horams.com.br · aredacao.com.br · contilnetnoticias.com.br
- [● 3 SOURCES] Dysport lot 025155 is classified as counterfeit. horams.com.br · aredacao.com.br · contilnetnoticias.com.br
- [● 4 SOURCES] Anvisa banned Keytruda lots Z005197 and Z012354 due to suspected falsification. horams.com.br · maisfm.com · aredacao.com.br · contilnetnoticias.com.br
- [● 3 SOURCES] Merck Sharp & Dohme (MSD) identified irregularities in Keytruda units in the market. horams.com.br · maisfm.com · contilnetnoticias.com.br
- [● 3 SOURCES] Anvisa ordered the seizure of Dysport lot 025155. horams.com.br · aredacao.com.br · contilnetnoticias.com.br
- [● 2 SOURCES] Brazil is the second country to authorize Emrelis, following the United States. oantagonista.com.br · olhardigital.com.br
- [○ 1 SOURCE] Anvisa approved Emrelis (telisotuzumab vedotin) for adults with advanced or metastatic non-small cell lung cancer. oantagonista.com.br