Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed b…
Ascend Laboratories, LLC · Out of specification due to dissolution.
- Status
- Ongoing
- City
- Bedminster
- State
- NJ
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 100053
- Recalling firm
- Ascend Laboratories, LLC
- Address 1
- 135 Us Highway 202 206 Ste 15
- Postal code
- 07921-2608
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
- Recall number
- D-0045-2027
- Product quantity
- 11,424 bottles.
- Reason for recall
- Out of specification due to dissolution.
- Recall initiation date
- 20261006
- Center classification date
- 20261016
- Report date
- 20261028
- Code info
- Lot # 25120696, Exp Date: December 31, 2026.
- Product description
Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
- Harmonized identifiers (openFDA)
- Application number
- ANDA209042
- Brand name
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Generic name
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer name
- Ascend Laboratories, LLC
- Product NDC
- 67877-499, 67877-500, 67877-501, 67877-502
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- AMLODIPINE BESYLATE, OLMESARTAN MEDOXOMIL
- RxCUI
- 730861, 730866, 730869, 730872
- SPL ID
- 32238052-6c4c-4b29-a59e-524c819c69f1
- SPL set ID
- c1204fbe-d086-43cf-bbaa-efec9cd0487c
- Package NDC
- 67877-499-30, 67877-499-90, 67877-500-30, 67877-500-90, 67877-501-30, 67877-501-90, 67877-502-30, 67877-502-90
- Is original packager
- true
- UNII
- 6M97XTV3HD, 864V2Q084H