Teva recalls antibiotic and anti-seizure drug

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Teva recalls antibiotic and anti-seizure drug

Genéricos/Novedades | Posted 30/09/2016 0 Post your comment

Recent US Food and Drug Administration (FDA) reports have caused Israeli generics producer Teva Pharmaceutical Industries (Teva) to recall a treatment for seizures, as well as an antibiotic made at its sterile manufacturing plant in Hungary.

The recalls began in May 2016 when Teva was forced to withdraw divalproex sodium tablets, which are used to prevent seizures in conditions such as epilepsy, as well as bipolar disorder and migraines. An FDA enforcement report revealed that the drug failed tablet/capsule specifications and was designated as a class III recall (where the product is ‘not likely to cause adverse health consequences’). Despite this being the lowest level of health hazard in an FDA recall, the Israeli drugmaker was forced to recall over 14,000 units of the drug.

Shortly after, Teva announced it was also recalling an antibiotic produced at its sterile manufacturing site in Hungary. The site was placed on the FDA’s import alert list in May 2016 after inspections revealed non-compliance with good manufacturing practices. Although the antibiotic (amikacin, which is used to treat severe infections such as multidrug-resistant bacterial infections picked up in hospital) was not banned by FDA, Teva announced it was recalling the drug due to the presence of very small pieces of glass. Such contamination could cause swelling or more serious blood clots, although the company said they had not received any reports of adverse reactions.

After FDA banned all but two products made at the Hungarian plant, Teva began working with the regulatory authorities to restart manufacturing as soon as possible. Despite these efforts, Hungary lost access to around 200 drugs as a result of the shutdown. The Hungarian authorities are now working closely with Teva to avoid shortages of critical drugs such as morphine and anticancer medications.

This news coincides with Teva’s ongoing efforts to purchase Allergan’s generics business ‘Actavis Generics’ for over US$40 billion. As the world’s largest generics producer, Teva’s efforts to purchase Actavis have come under close scrutiny, however, the merger was recently approved after the company agreed to sell the rights and assets to 79 of its pharmaceutical products [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Dr Reddy’s to buy US generics from Teva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 15]. Available from: www.gabionline.net/Generics/News/Dr-Reddy-s-to-buy-US-generics-from-Teva

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Source: US FDA