FDAFDA · Food and drugs·Recall number D-0828-2020
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Published February 12, 2020 · Recall initiated: January 24, 2020
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
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories LLC
- Distributor
- Nationwide in the U.S.
- UPC
- 0367877445304
- Lot
- Lot #: 19122552, Exp 7/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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