Ascend Laboratories, LLC: Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; D
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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Ascend Laboratories, LLC
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
- Reason / hazard
- Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2026-07-08
- Code info
- Lot 25121311, expiry 3/31/2028
- Product quantity
- 6,192 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bedminster
- State
- NJ
- Country
- United States
- Event id
- 99385
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