Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Failed Dissolution Specifications: low dissolution results
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Reason cGMP deviations
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.