The recall was conducted in coordination with the US Food and Drug Administration (FDA), after finished product batches were manufactured with active pharmaceutical ingredient (API) produced by Hetero Labs – a company involved in previous recalls.
Torrent Pharmaceuticals will recall three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide tablets.
The recall was instigated after the impurity N-Methylnitrosobutyric acid (NMBA) was detected at levels above the acceptable daily intake levels, as specified by the FDA.
Torrent had previously recalled 104 lots of the same medicines, after NMBA was found in the API, also manufactured by Hetero.
In total, this is the sixth recall that Torrent has issued regarding losartan medications, which are used to treat hypertension and nephropathy in type 2 diabetic patients.
According to the company, it is arranging for a return of all recalled products and notifying its distributors and customers to immediately discontinue distribution of the affected lots.
The recall was announced amid a separate wave of recalls being made regarding potential contamination of ranitidine medicine, which resulted in Sandoz initiating a recall of its products.
