FDA-Drug2018-12-12Class III

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

Aurobindo Pharma USA Inc.
Hazard

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).

Sold states
U.S.A. Nationwide
Affected count
4464 bottles
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0289-2019

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