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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Atorvastatin Calcium Tablets Recalled for Impurity and Degradation Issues

Agency Publication Date: June 11, 2021
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Summary

Dr. Reddy's Laboratories is recalling 5,984 bottles of Atorvastatin Calcium (the generic version of Lipitor) 10 mg tablets due to the presence of chemical impurities. The medication failed quality testing because it exceeded specifications for certain degradation products known as ATV cyclo impurities. These prescription tablets were distributed nationwide across the United States in 500-count bottles. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lots.

Risk

The presence of these impurities means the medication has degraded and no longer meets the required purity and safety specifications, which could potentially impact the drug's effectiveness or safety profile.

What You Should Do

  1. Check your Atorvastatin Calcium prescription bottle for NDC 55111-121-05 and a 500-count size.
  2. Locate the lot number and expiration date on the side of the bottle to see if it matches lot C905064 or C905065 with an expiration date of 07/2021.
  3. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance and to obtain a replacement prescription.
  4. Do not stop taking your cholesterol medication without first consulting a healthcare professional, as the risk of suddenly stopping the drug may be greater than the risk from the impurities.
  5. Return any unused portions of the recalled medication to your pharmacy for a refund and contact Dr. Reddy's Laboratories for further instructions.
  6. For additional information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Atorvastatin Calcium Tablets, USP 10 mg (500-count bottle)
Model:
NDC 55111-121-05
Lot Numbers:
C905064 (Exp. Date 07/2021)
C905065 (Exp. Date 07/2021)
Date Ranges: 07/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88041
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 5984 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.