Reported Aug 22, 2018 · Terminated

Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam -…

Dr. Reddy's Laboratories, 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: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623

Is this the product you have?

  • Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only
  • Mfd By
    • Dr. Reddy's Laboratories Limited
    • Srikakulam - 532 409 India
    • NDC 55111-123-05
Lot codes and dates
  • T60045
Amount recalled
2280 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.

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 Apr 15, 2020 · Data as of Sep 19, 6:32 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.