US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 15, 2021 (5 years ago)

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What was recalled

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328

Recalling firm
Cardinal Health Inc.
NDC code
60631-412-30
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0430-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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