US-based pharma company Allegiant Health is recalling over 85,000 cartons of heartburn relief tablets in the US made by Wockhardt in India.
This voluntary recall is attributed to purported failure of the Indian drug maker to adequately investigate customer complaints.
According to the Enforcement Report for the week of June 24, 2015, the US health regulator has said 86,106 cartons of over-the-counter (OTC) Famotidine tablets USP of 20 mg are being voluntarily recalled by Allegiant Health.
“The Class II ongoing recall is initiated and the reason for recall is CGMP deviations: failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints,” US Food and Drug Administration (USFDA) said in the report.
A Class II recall is undertaken in a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Wockhardt closed at 1,381.60 on BSE, down 3.15 per cent.