FDAClass IIISeptember 2, 2015

Amlodipine besylate and Atorvastatin calcium Tablets recall: Subpotent

Amlodipine 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

Why was Amlodipine besylate and Atorvastatin calcium Tablets recalled?

Subpotent Drug: Subpotent atorvastatin.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) Lot #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015

Product
Amlodipine 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 firm
Dr. Reddy's Laboratories, Inc.
Quantity
a) 16,080 and b) 480 Bottles
Distribution
U.S. Nationwide
Recall date
September 2, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls