Reported Apr 22, 2020 · Terminated

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

Aurobindo Pharma USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aurobindo Pharma USA Inc. · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401

Is this the product you have?

  • Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only
  • Distributed byAurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Lot codes and dates
    • Lot #: 05319004A1
    • Exp. Date 03/2022
Amount recalled
26976 units

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 25, 2024 · Data as of Sep 19, 8:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.