US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 18, 2020 (6 years ago)

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma…

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

Why it was recalled

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

What was recalled

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

Recalling firm
Aurobindo Pharma USA Inc.
NDC code
65862-053-90
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1234-2020

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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