Antidepressant Recalled

The US Food and Drug Administration (FDA) reported a recall of venlafaxine hydrochloride extended-release capsules, USP, 75mg, in 30-, 90-, and 1000-count bottles.

The impacted lots are listed below.

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What prompted the Class II nationwide recall? Zydus Pharmaceuticals USA, the recalling firm, noted that the recall was launched after discovering that the dissolution results of retained samples were out of specification.

The products were manufactured by Cadila Healthcare Ltd. in Ahmedabad, India.

This recall echoes a similar one from earlier this year when Zydus recalled more than 9,500 bottles of risperidone orally disintegrating tablets. In 2014, Cadila was under scrutiny by the FDA regarding manufacturing issues, according to a Reuters report.

--Stephanie Vaccaro

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of August 24, 2016. www.fda.gov. Accessed August 24, 2016.