Drug firms Lupin and Cadila Healthcare are recalling more than 100,000 units of Duloxetine delayed-release capsules and 19,812 bottles of Paroxetine tablets, respectively, from the US market, the US health regulator has said.
Lupin Pharmaceuticals is recalling 1,11,648 units of Duloxetine delayed-release capsules USP, in the strength of 30 mg, on account of failed dissolution specification, the United States Food and Drug Administration said in its latest enforcement report.
The drug was manufactured by Lupin Goa, the report added. The ongoing voluntary nationwide recall is a class-III recall, it said.
Zydus Pharmaceuticals USA, arm of Cadila Healthcare, is also recalling 19,812 bottles of Paroxetine tablets in the strength of 30 mg from the US market. The reason for the ongoing voluntary nationwide recall is “presence of foreign tablets/capsules: Risperidone tablets were found in bottle of Paroxetine tablets”, the report stated.
The product was manufactured by Cadila Healthcare and the recall is a class-II recall, the regulator added.
A class-II recall is initiated 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”.
A class-III recall, on the other hand, kicks in where use of or exposure to a violative product is not likely to cause adverse health consequences.