D-0289-2019 Class III Terminated
FDA drug recall D-0289-2019 was initiated by Aurobindo Pharma USA Inc. on Nov 30, 2018 and is designated Class III. 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). The recall status is terminated (terminated Feb 1, 2022). Affected quantity: 4464 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 12, 2018
- Initiation Date
- Nov 30, 2018
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0289-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026