Aurobindo Pharma USA Inc. recalls Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA…

Recall date

November 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0289-2019

FDA classification

Class III

Brand / firm

Aurobindo Pharma USA Inc.

Sold / distributed

U.S.A. Nationwide

Why it was 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).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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