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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 numbera) Lot #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015
Where it was soldU.S. 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

Subpotent Drug: Subpotent atorvastatin.

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.
NDC43598-318-30
Show the full FDA record
Full product labelAmlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionU.S. Nationwide
Quantitya) 16,080 and b) 480 Bottles
Recall initiated2015-08-13
Report date2015-09-02
Recall completed2016-12-15
Recall numberD-1377-2015
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.