Cadila Healthcare Ltd. and Lupin Ltd. are recalling their Paroxetine and Duloxetine drugs from the U.S. market. Regulators in the United States claim that 19,812 bottles of Paroxetine and 111, 648 units of their Duloxetine, delayed-released capsules are being taken off store shelves. The capsules being recalled are of the 30mg strength.
The recall was initiated due to the failure of dissolution specification, according to the USFDA.
The recall is voluntary and a class III recall. Cadila Healthcare’s Zydus Pharmaceuticals is recalling 30mg tablets of their Paroxetine drug. The recall is being initiated due to foreign tablets or capsules. The report noted that the company’s bottles were found to contain Risperidone tablets.
A class II recall is a result of a situation, in this case the presence of foreign tablets, that may cause reversible health consequences. The risk of serious health issues is remote.
Duloxetine is a drug that’s prescribed to patients suffering from anxiety and depression. The drug has also been linked to potential benefits for women with breast cancer. The drug may be effective when managing aromatase inhibitors.
Duloxetine is also prescribed as a pain reliever for people who suffer from back pain, arthritis and diabetes.
Paroxetine is prescribed to patients who are suffering from anxiety, depression and obsessive-compulsive disorders. The drug is sold under the Paxil, Brisdelle, Paxil CR and Pexeva brands.
Lupin was at the center of an FDA warning in mid-November after the agency warned that the company’s generic drug quality was not up to par. The FDA found that Lupin ignored over 100 out-of-spec findings. The warning came after a 2015 and 2016 study that found 134 instances where Lupin’s drugs and ingredients failed initial testing.
Lupin overrode the results, citing “laboratory errors.” The FDA warning cited “significant violations.” There has been no verification on whether the recall is linked to the warning.