The product is used to prevent pregnancy. It is manufactured in India and then supplied in the US market by Lupin Pharmaceuticals Inc, the report said.
One pouch of Mibelas 24 Fe contains 28 chewable tablets.
The reason for the recall is “failed impurities/degradation specifications: Out of specification result observed in related substance test”, the USFDA said.
The nationwide (US) recall was initiated by the company on July 21 this year and the USFDA classified it as a Class II recall.
As per the US health regulator, a class II recall is initiated in a “situation in which the 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 company did not elaborate if the product is also sold in India. A mail sent to the company in this regard remained unanswered.
Usually, drug firms cater to the domestic market from separate manufacturing plants. The USFDA approved facilities are specifically utilised to cater to the US, the largest market for pharmaceutical products in the world.