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

Pravachol 40mg 90; Ndc/Upc 3519410; Rx; Tablets

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

PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS

Recalling firm
Cardinal Health Inc.
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0460-2021

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.