FDAClass IIIDecember 12, 2018

Amlodipine and Olmesartan Medoxomil Tablets recall

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30

Why was Amlodipine and Olmesartan Medoxomil Tablets recalled?

Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).

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?

Lot#: OWSA18002-A, Exp 7/2020

Product
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
4464 bottles
Distribution
U.S.A. Nationwide
Recall date
December 12, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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