Bupropion Hydrochloride Recalled

Bupropion Hydrochloride extended-release tablets, USP (XL) 300 mg, are being voluntary recalled by Zydus Pharmaceuticals USA Inc.

The nationwide recall was initiated on August 3 due to “Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point,” according to the latest US Food and Drug Administration (FDA) Enforcement Report. The recall is currently in progress.

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Nearly 2500 units of the prescription drug are included in the recall. The impacted product has the following code information: Lot # MR3365, Exp. Feb 17.

The FDA classified this as a Class III recall on November 22. A Class III recall is described by the FDA as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”

The recalled product, which is indicated for the treatment of major depressive disorder, was manufactured by Cadila Healthcare Ltd in Ahmedabad, India.—Meredith Edwards White

Sources

https://www.accessdata.fda.gov/scripts/ires/index.cfm

https://www.fda.gov/Safety/Recalls/ucm165546.htm