Wockhardt Ltd is recalling 1,09,744 bottles of anti-hypertensive drug, Metoprolol, belonging to multiple lots from the American market following failure of dissolution test, US health regulator FDA said.
According to a notification by the U.S. Food and Drug Administration (USFDA), the recall is voluntary and was initiated by the company from April 1 under ‘Class-II’ classification.
Metoprolol is a generic version of AstraZeneca Plc’s branded drug Toprol.
“Failed Dissolution Specifications: failure of dissolution test observed at nine month time point,” the regulator’s website said as the reason for recall.
Tablet Dissolution is a standardised method for measuring the rate of drug release from a dosage form.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, were manufactured by Wockhardt Ltd, Mumbai, and distributed in the USA by Wockhardt USA LLC.
According to the USFDA, Class II recall is 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.
The Wockhardt scrip was down 1.14 per cent, at Rs 786.20, on the BSE in the afternoon.