Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by...
FDA Recall #D-0289-2019 — Class III — November 30, 2018
Product Description
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
Reason for Recall
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).
Recalling Firm
Aurobindo Pharma USA Inc. — East Windsor, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4464 bottles
Distribution
U.S.A. Nationwide
Code Information
Lot#: OWSA18002-A, Exp 7/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated