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Class III · Lower riskRecall completed

Atorvastatin Calcium

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: C905064, C905065, Exp. Date 07/2021
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byDr. Reddy's Laboratories Limited
Brand nameATORVASTATIN CALCIUM
Generic nameATORVASTATIN CALCIUM
Active ingredient(s)ATORVASTATIN CALCIUM TRIHYDRATE
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC55111-121-05
Show the full FDA record
Full product labelAtorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide within the United States
Quantity5984 bottles
Recall initiated2021-06-04
Report date2021-06-23
Recall completed2023-02-16
Recall numberD-0629-2021
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.