Amikacin recalled by Teva after US shortage ends

Teva recalls injectable antibiotic in US over contamination concerns

By Gareth Macdonald contact

- Last updated on GMT

Teva injectables manufacturing facility in Godollo, Hungary
Teva injectables manufacturing facility in Godollo, Hungary

Related tags: Pharmaceutical drug

Teva has recalled an injectable antibiotic that is one of only two products currently made at the Godollo, Hungary facility that was hit with a US import ban in May.

The Israeli drug manufacturer announced it was withdrawing seven lots of amikacin sulfate injection in the US last week​.

The firm said the voluntary recall was prompted by concerns the affected products were contaminated with “glass particulate matter​.”

The facility in Godollo, on the outskirts of Budapest, was issued with an import alert​ in May.

US Food and Drug Administration (FDA) inspectors who visited in January identified several deviations from current good manufacturing practices (GMP).

Teva responded to the alert by halting production of around 200 drugs previously made at the site while it addressed the issues.

Shortage? 

Amikacin sulfate – which is used to treat hospital-acquired infections - is one of only two products Teva continued to make at the site, the other being the cancer medication bleomycin.

Previously both products were identified as being in short supply in the US. However, as of August 9​, only bleomycin is on the US FDA shortage list.

Karen Jackler, CDER spokeswoman confirmed this, telling us "Amikacin is not in shortage​."

Related topics: Markets & Regulations, QA/QC, Regulations

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