Reported Sep 4, 2019 · Terminated

Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810…

Aurobindo Pharma USA Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 40 mg. Rx
  • Only 1000 Count Bottles Manufactured byAurolife Pharma
  • LLC Dayton NJ 08810 Manufactured forAurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Lot codes and dates
    • 05318054B
    • exp 3/2021
Amount recalled
2,352/1000 count bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 28, 2021 · Data as of Sep 19, 6:39 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.