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EMS generic oral antidiabetic package is suspended

11/1/2016

This article was translated by an automatic translation system, and was therefore not reviewed by people.

 

 

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Company EMS has notified Anvisa of possible label errors in a batch of Pioglitazone Hydrochloride

By: Ascom / Anvisa

Posted: 10/31/2016 15:52

Last Modified: 10/31/2016 15:55 

Anvisa suspends lot 822182 of the generic drug Pioglitazone Hydrochloride on Monday (31/10). The company EMS S / A which manufactures the oral antidiabetic used for glycemic control has informed the Agency of a possible error in the description of the dosage on the packaging of the medicine.

According to the company's announcement, there are the possibility that some packs of the product Pioglitazone Hydrochloride 30 mg x 15 tablets have been labeled with the product Pioglitazone Hydrochloride 15 mg.

Therefore the product can not be distributed, marketed and used. The measure applies only to lot 822182 of the generic drug. The company EMS will collect the stock of the lot in question.

Check resolution RE 2.929 / 16 published in the Official Gazette (DOU) this Monday (31/10).

 

Source: Anvisa

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