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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 19122552, Exp 7/31/2021
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0828-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 24, 2020
- FDA report date
- Feb 12, 2020
- Quantity
- 192 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0828-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84818
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot #: 19122552, Exp 7/31/2021
- Postal code
- 07054-3707
- Report date
- Feb 12, 2020
- Product type
- Drugs
- Recall number
- D-0828-2020
- Classification
- Class II
- Recalling firm
- Ascend Laboratories LLC
- Product quantity
- 192 Bottles
- Termination date
- Oct 29, 2021
- Reason for recall
- cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jan 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 6, 2020