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Aurobindo Pharma Ltd has recalled many lots of Mirtazapine 45 mg tablets from the US market, according to an Enforcement Report of the US Food and Drug Administration (USFDA).
The recall was initiated “due to the product not meeting a specification for a known degradation product during routine stability testing ,'' the US regulator said.
The drug is an anti-depressant and generally indicated for treatment of mood disorders.
According to USFDA report, the volume of product in commerce in the nation wide market in the US was 66,915 bottles.
When contacted, the company preferred not to respond on the issue.
The Hyderabad-based company has said early this week that it had received ‘warning letter' from the US with regard to its antibiotics manufacturing unit in Hyderabad.
In February, the USFDA had imposed an import alert on its cephalosporin-producing Unit VI located at Chitkul village in Hyderabad and also asked the company to submit an action plan on rectifying ‘non-compliance' with packaging and labelling norms at Unit III of the facility.
Aurobindo is likely to discuss these issues with USFDA officials next month, according to sources.
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