Mylan latest to recall blood pressure generics

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Mylan latest to recall blood pressure generics

Generics/News | Posted 31/10/2014 0 Post your comment

US generics giant Mylan has become the latest in a line of generics companies that have faced recalls of the blood pressure medication metoprolol.

The drug is a generic of AstraZeneca’s hypertension drug Toprol XL (metoprolol). Toprol XL is a beta-blocker used to treat angina (narrowed arteries) and high blood pressure.

Mylan is carrying out a voluntary recall of almost 16,000 bottles of its metoprolol succinate extended-release tablets. The recall comes as a result of a pharmacist’s report of a rogue tablet of a different size and markings in a bottle of Mylan’s metoprolol.

In May 2014, FDA recalled more than 13,000 bottles of metoprolol extended release tablets manufactured by Indian generics maker Dr Reddy’s Laboratories. This was followed by a recall of more than 100,000 bottles of generic metoprolol from India-based generics maker Wockhardt. In both cases the generics were recalled due to the failure of dissolution tests [1].

The US Food and Drug Administration has already received thousands of complaints from doctors and patients about generics of the metoprolol [2]. This has resulted in the agency including blood-pressure generics in its planned testing on generics, which the agency has been carrying out since September 2013 [3]. Generics produced by US-based generics makers Actavis and Mylan, as well as India-based generics makers Dr Reddy’s Laboratories and Wockhardt will be included in the study [2].

References
1.     GaBI Online - Generics and Biosimilars Initiative. Recalls call into question metoprolol generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Generics/General/Recalls-call-into-question-metoprolol-generics
2.     GaBI Online - Generics and Biosimilars Initiative. Blood pressure generics to be included in FDA’s testing plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Generics/News/Blood-pressure-generics-to-be-included-in-FDA-s-testing-plans
3.     GaBI Online - Generics and Biosimilars Initiative. FDA starts widespread testing of generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Generics/General/FDA-starts-widespread-testing-of-generics

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Source: US FDA