More Than 1.4 Million Bottles of Antidepressant Recalled

The most recent Enforcement Report from the US Food and Drug Administration (FDA) announced two recalls of an antidepressant that totaled more than 1.4 million bottles.

Both recalls involved duloxetine delayed-release capsules, USP, 60 mg. The first involves 2,077 1,000-count bottles manufactured by Laboratorios del Dr. Esteve in Spain (NDC 60429-166-10). The impacted lots were #GS011709 and #GS012352.

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The FDA also reported another recall of more than 1.4 million bottles of the antidepressant manufactured by Apotex in Canada.

What prompted the Class III recall of duloxetine delayed-release capsules, USP, 60 mg, 30-count bottles (NDC 60505-2997-3)? When the product was tested for stability, it failed dissolution specifications.

The ongoing recall, launched in January, was first mentioned in the FDA’s Enforcement Report this week.

Apotex is no stranger to manufacturing issues. In March, Golden State Medical Supply launched a recall of statins made by Apotex. In 2014, the FDA banned Apotex from importing drugs made at its plant in India, Reuters reported. That ban excluded Riluzole.

Click here to read the report.

--Stephanie Vaccaro

Reference:

US Food and Drug Administration. FDA Enforcement Report – Week of July 20, 2016. www.fda.gov. Accessed July 21, 2016.