December 08, 2017
Zydus Pharmaceuticals USA Inc. is recalling nearly 20,000 bottles of paroxetine tablets after risperidone was discovered in 1 of the bottles, according to the December 6, 2017, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 30-count bottles of paroxetine (NDC 68382-099-06) from lot Z701308, 500-count bottles of paroxetine (NDC 68382-099-05) from lot Z701309, and 1000-count bottles of paroxetine (NDC 68382-099-10) from lot Z701310. The expiration date for the lots is April 2019. The tablets were manufactured by Cadila Healthcare and distributed by Zydus Pharmaceuticals.
Zydus Pharmaceuticals issued the voluntary recall November 20, 2017. The FDA designated it Class II November 30, 2017, advising use of the tablets could cause temporary or reversible adverse effects. The probability of serious adverse consequences is remote.
Both paroxetine and risperidone are prescription medications for mental health. Paroxetine is a selective serotonin reuptake inhibitor used to treat disorders including depression, obsessive-compulsive disorder, anxiety, panic attacks, and post-traumatic stress disorder. Risperidone is an antipsychotic used to treat schizophrenia, bipolar disorder, and irritability associated with autism.
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