Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
FDA recall notice · announced June 2, 2021 · Cardinal Health
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Notes
Distribution: FL, GA, SC
Lot/code information: 78902-1
Quantity: 328 bottles
Status: Terminated
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Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.