Reported Feb 12, 2020 · Terminated
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai -…
Ascend Laboratories LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
Olmesartan Medoxomil Tablets 20 mgRx Only90 Tablets per Bottle
- Manufactured byAlkem Laboratories Ltd., Mumbai - 400 013 INDIA
- Distributed byAscend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90
- Lot codes and dates
Lot #: 19122552Exp 7/31/2021
- Amount recalled
- 192 Bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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