Recalls / Class III
Class IIID-0392-2021
Product
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
- Brand name
- Olmesartan Medoxomil
- Generic name
- Olmesartan Medoxomil
- Active ingredient
- Olmesartan Medoxomil
- Route
- Oral
- NDCs
- 67877-445, 67877-446, 67877-447
- FDA application
- ANDA206763
- Affected lot / code info
- Batch No. 20122548, Exp Date: Aug. 2022
Why it was recalled
Presence of Foreign Tablet/Capsule
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 34296 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-04-29
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2023-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0392-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.