PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 12, 2018 Initiated: November 30, 2018 #D-0289-2019

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).

Details

Recalling Firm
Aurobindo Pharma USA Inc.
Units Affected
4464 bottles
Distribution
U.S.A. Nationwide
Location
East Windsor, NJ

Frequently Asked Questions

What product 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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 4464 bottles.
Why was this product 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).
Which agency issued this recall?
This recall was issued by the FDA Drug on December 12, 2018. Severity: Low. Recall number: D-0289-2019.