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Recall Active for Serotonin Reuptake Inhibitor

September 22, 2017

Zydus Pharmaceuticals USA Inc. is voluntarily recalling nearly 45,000 bottles of paroxetine tablets, USP (NDC 68382-099-06), because they may contain the antipsychotic risperidone, according to the September 20, 2017, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 30-mg paroxetine tablets in 30-count bottles from lot Z701133, which expires in March 2019. The bottles were manufactured by Cadila Healthcare and were distributed by Zydus Pharmaceuticals across the United States.

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Zydus Pharmaceuticals initiated the recall August 18, 2017. On September 11, 2017, the FDA designated the recall Class II, indicating that while the likelihood of serious harm is remote, use of the affected product could cause temporary or reversible adverse effects.

Paroxetine is a selective serotonin reuptake inhibitor prescribed for the treatment of depression, anxiety, obsessive-compulsive disorder, or premenstrual dysphoric disorder.

Jolynn Tumolo

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