Wrong Labelling: Intas Pharma US arm recalls over 46,000 bottles of diuretic drug

Accord Healthcare recall is based on "Labelling: label mix-up: customer complaint that a sealed bottle labelled as Hydrochlorothiazide tablets USP 12.5 mg contained only Spironolactone tablets USP 25 mg,"

New Delhi: Accord Healthcare Inc, the US arm of Intas Pharmaceuticals, is recalling over 46,000 bottles of Hydrochlorothiazide tablets manufactured by the Ahmedabad-based firm, on account of labelling mix-up, USFDA said. Intas Pharmaceuticals Ltd. through its wholly-owned subsidiary Accord Healthcare Ltd.

Hydrochlorothiazide tablets belong to a class of drugs known as diuretics and are used for the treatment of high blood pressure and edema.

Accord Healthcare is recalling 46,632 bottles of Hydrochlorothiazide tablets USP in the strength of 12.5 mg, the Enforcement Report by United States Food and Drug Administration (USFDA) said.

The reason for the recall is "Labelling: label mix-up: customer complaint that a sealed bottle labelled as Hydrochlorothiazide tablets USP 12.5 mg contained only Spironolactone tablets USP 25 mg," it added.

The voluntary nationwide recall in the US and Puerto Rico has not been classified yet, the report said.

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