Anvisa determines seizure of counterfeit batch of arthritis medicine | Brazil


Covid self-test: Anvisa has at least 30 registration requests under evaluationMarcelo Camargo/Agência Brasil

Published 04/05/2022 16:18 | Updated 05/04/2022 16:20

Brasília – The National Health Surveillance Agency (Anvisa) determined this Wednesday (4) the seizure and ban on the distribution, marketing and use of counterfeit units of batch 1146607 (fab 05/2021, val 01/2023) of the Humira drug. AC 40 mg, as a pre-filled syringe.

The product is used by patients with severe rheumatoid arthritis. The measure was disclosed through Resolution-RE 1.413/2022, published in today’s edition of the Official Gazette of the Union.

The decision was taken after the company holding the registration, AbbVie Farmacêutica Ltda., informed Anvisa about the falsification of a syringe filled with the product.

According to the pharmacist, the counterfeit batch has differences from the original drug. Among the problems identified in the fraud are, for example, differences in closure, color and font size of the blister, in the color of the security marking, in the different dimensions of the packaging, in addition to the absence of the braille marking on the secondary packaging. Anvisa is investigating the case.

This is not the first Resolution on the drug with the same content published by Anvisa. The other, number 3,744/2021, referred to batch 1135258 (fab. 05/2020, val. 04/2022).

“Anvisa asks the health services that, if they receive units of the aforementioned drug, before using them, they do a thorough check of the packaging and label of the product. If units with the characteristics of counterfeiting described above are identified, do not use the products and report the fact immediately to the Agency, preferably through the Notivisa system,” the agency advised in a statement.

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