Clipping of news on Brazilian Culture, Law and Citizenship
06/05/2017
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Altogether 45 batches of the generic clopidogrel bisulfate drug from Actavis Pharmaceuticals were suspended.
By: Ascom / Anvisa
Posted: 06/06/2017 10:46
Last Modified: 06/05/2017 00:04
Anvisa has suspended the distribution, sale and use of 45 batches of the generic drug clopidogrel bisulfate 75mg. Coated tablets indicated for the prevention of atherothrombotic events, such as acute myocardial infarction (MI) or stroke, showed unsatisfactory laboratory results.
According to the statement sent by the manufacturer company Actavis Farmacêutica Ltda, the lots in question showed deviations out of specification for the test of related substances (impurity A). In addition to this test, the drug showed questionable dissolution results during the conduction of accelerated and long-term stability studies.
Resolution No. 1,459 of June 2, 2017 also determines that the company Actavis Farmacêutica Ltda promotes the collection of the committed lots.
Check out the suspended lots below:
|
Presentation |
Lot | Shelf life | Lot | Shelf life |
|
Clopidogrel bisulfate 75mg tablet coated in clear plastic aluminum blister with 100 units
|
12256 12265 12323 12432 12444 12497 12645 12646 12678 12775 12776 12434 |
Ago/17 Ago/17 Ago/17 Out/17 Out/17 Dez/17 Jan/18 Jan/18 Jan/18 Mar/18 Mar/18 Out/17 |
12915 12916 13037 13090 13178 13179 13375 13416 13417 12255 12567 12585 |
Mai/18 Mai/18 Jul/18 Jul/18 Jul/18 Jul/18 Nov/18 Nov/18 Nov/18 Ago/17 Out/17 Out/17 |
|
Clopidogrel bisulfate 75mg film-coated plastic blister pack with 28 units
|
12486 12496 12677 12754 12774 12798 12845 12872 12914 12928 |
Out/17 Dez/17 Jan/18 Mar/18 Mar/18 Mar/18 Mar/18 Mar/18 Mai/18 Mai/18 |
13004 13005 13087 13089 13256 13180 13181 13366 13379 13415 |
Mai/18 Mai/18 Jul/18 Jul/18 Jul/18 Jul/18 Ago/18 Out/18 Nov/18 Nov/18 |
|
Clopidogrel bisulfate 75mg film-coated tablet in clear plastic aluminum with 14 units |
12322 |
Ago/17 |
|
|
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Source: Anvisa
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This article was translated by an automatic translation system, and was therefore not reviewed by people.