New Delhi, Dec 7 (PTI) Drug firms Lupin and CadilaHealthcare are recalling nearly 1.11 lakh units of Duloxetinedelayed-release capsules and 19,812 bottles of Paroxetinetablets, respectively, from the US market, the US healthregulator has said.
Lupin Pharmaceuticals is recalling 1,11,648 units ofDuloxetine delayed-release capsules USP, in the strength of30 mg, on account of failed dissolution specification, theUnited States Food and Drug Administration (USFDA) said in itslatest Enforcement Report.
The drug was manufactured by Lupin Goa, the report added.
The ongoing voluntary nationwide recall is a class IIIrecall, it said.
Zydus Pharmaceuticals USA Inc, arm of Cadila Healthcare,is also recalling 19,812 bottles of Paroxetine tablets in thestrength of 30 mg from the US market.
The reason for the ongoing voluntary nationwide recall is"presence of foreign tablets/capsules: Risperidone tabletswere found in bottle of Paroxetine tablets", the reportstated.
The product was manufactured by Cadila Healthcare and therecall is a class II recall, the regulator added.
A class II recall is initiated in a "situation in whichuse of or exposure to a violative product may cause temporaryor medically reversible adverse health consequences or wherethe probability of serious adverse health consequences isremote".
A class III recall, on the other hand, kicks in where useof or exposure to a violative product is not likely to causeadverse health consequences. PTI AKTARD.
This is unedited, unformatted feed from the Press Trust of India wire.