FDARecalled Aug 20, 2025 · #D-0576-2025
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, ...
Hazard
Class II — temporary health risk
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Failed Dissolution Specifications: low dissolution results Classification: Class II Distribution: Nationwide in the USA
Product details
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
- Type
- Drugs
- Manufacturer
- Ascend Laboratories, LLC
- Model numbers
- 23121560
- UPCs
- —