D-0289-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 12, 2018
- Initiation Date
- November 30, 2018
- Termination Date
- February 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4464 bottles
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).
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot#: OWSA18002-A, Exp 7/2020