Recalls / Class II
Class IID-0828-2020
Product
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.
- 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
- Lot #: 19122552, Exp 7/31/2021
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.
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
- 192 Bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-01-24
- FDA classified
- 2020-02-06
- Posted by FDA
- 2020-02-12
- Terminated
- 2021-10-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0828-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.