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Class III · Lower riskRecall completed

Amlodipine Besylate And Atorvastatin Calcium

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

Does this affect you?
Check your lot numberLot #: a) C401536, Exp 07/2015; b) C401538, Exp 07/2015
Where it was soldNationwide
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

Subpotent drug

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 Bachupally, 500 090 India foreign manufacturer
Brand nameAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Generic nameAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Active ingredient(s)AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM TRIHYDRATE
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC43598-322-30
Show the full FDA record
Full product labelAmlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count bottle (NDC 43598-322-90), Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Bachupally, 500 090 India
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide
Recall initiated2015-05-06
Report date2015-06-24
Recall completed2016-03-31
Recall numberD-1143-2015
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Amlodipine recallsAtorvastatin 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.