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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 numberT60045
Where it was soldU.S.A. Nationwide
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 - 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.

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.
NDC55111-123-05
Show the full FDA record
Full product labelAtorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionU.S.A. Nationwide
Quantity2280 bottles
Recall initiated2018-08-02
Report date2018-08-22
Recall completed2020-04-15
Recall numberD-1079-2018
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Atorvastatin recallsRecent drug recallsCheck another medication

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.