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Torrent Pharma recalls 1.7 mn bottles of BP drug from US over quality norms

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA

Press Trust of India  |  New Delhi 

Torrent Pharma recalls 1-mn bottles of BP drug from US over quality norms
All the ongoing voluntary recalls of the hypertension treatment drug are class II recalls

Drug firm Inc is recalling over 1.78 million bottles of treatment from the US and on account of deviations from current good manufacturing norms, according to a report of the US regulator.

The US-based arm of is recalling 133,992 bottles of USP in the strength of 25 mg manufactured by the parent company at its Mehsana facility, the Enforcement Report of the USFDA said.

The company is also recalling 476,340 bottles of USP, 50 mg from these markets, the Food and Drug Administration (USFDA) said.

Inc is recalling 121,668 bottles of tablets USP, 100 mg from and Puerto Rico, it added.

The company is also recalling / Hydrochlorothiazide tablets USP 50mg/12.5mg.

In addition, 172,296 bottles of Losartan Potassium / Hydrochlorothiazide tablets, USP 100mg/12.5mg are being recalled, it added.

is also recalling 173,760 bottles of these tablets in the strength of 100mg/25mg, the enforcement report said.

All the ongoing voluntary recalls of the treatment drug are class II recalls, it added.

The reason for the recalls is "CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million", the report said.

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA.

According to the USFDA, a class II recall is initiated in a situation "in which use of, or exposure to, a may cause temporary or medically reversible adverse consequences or where the probability of serious adverse consequences is remote".

First Published: Sun, April 21 2019. 11:35 IST
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