Label lapse: Brazil suspends ulcer drug

By Flora Southey contact

- Last updated on GMT

iStock/filipefrazao
iStock/filipefrazao
The Brazilian National Health Surveillance Agency (ANVISA) has suspended a batch of Omeprazole due to labelling defects.

Batch 486773A of Omeprazole, used to treat gastric ulcers, was manufactured by Sao-Paulo, Brazil-based Eurofarma Laboratorios.

Under Resolution RE 1,847 / 17, ANVISA suspended the distribution, marketing and use of the faulty lot – made 01/2017 and due to expire 12/2017 – on July 10.

In a statement released by the firm, distribution of the affected batch was immediately suspended, and recalled.

Omeprazole

Omeprazole – a proton pump inhibitor – can be used to treat a variety of conditions caused by excess stomach acid, including gastroesophageal reflux disease (GERD) and stomach ulcers.

The affected lot of generic drug Omeprazole 40mg is a lyophilized powder solution for injection.

While Eurofarma press officer Clareane Moraes did not disclose details of the labelling faults, she did tells us the suspended batch was intended for hospital use only, and is available exclusively to the Brazilian market.

According to Eurofarma’s withdrawal statement, other batches of Omeprazole may be marketed and used normally.

Related topics: Regulatory & Safety, Regulations

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