FDAFDA · Food and drugs·Recall number D-0289-2019
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
Published December 12, 2018 · Recall initiated: November 30, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- U.S.A. Nationwide
- UPC
- 0365862855305
- Lot
- Lot#: OWSA18002-A, Exp 7/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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